Eugia Pharma
FDA Approved Drugs

Eugia Pharma

FDA Approved Drugs Database

FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.

RX Discontinued Unclassified OTC
  • Total Records 256
  • Latest Approval Date Feb 25, 2026
  • Data Source FDA
  • First Approval Date Apr 26, 1994
All
256
View
Unclassified
12
View
Discontinued
71
View
OTC
2
View
RX
171
View
Company Overview

Company

Eugia Pharma

Country

India

Website

Visit Website

Email

info@eugia.co.in

Social Profiles

LinkedIn
Company Snapshot

Eugia Pharma

Forming part of Sy No 83/1, Hyderabad Knowledge City TSIIC Raidurg, Panmaktha Plot, 1, Hitech City Rd, opp. IKEA Hyderabad, Telangana 500081

India

www.eugiapharma.com/ info@eugia.co.in View on Map
FDA Approved Drug Records ( 256 records )
2020
21 Oct
RX Application: 210969

Drug Name

ACETAMINOPHEN

Product Number

1

Dosage Form

-

Strength

1GM/100ML (10MG/ML)

Approval Date

2020-10-21

210969 / 1

Active Ingredient

ACETAMINOPHEN

Application Number

210969

Product Number

1

Dosage Form

-

Strength

1GM/100ML (10MG/ML)

Approval Date

2020-10-21

Regulatory Status

RX

2016
29 Feb
RX Application: 207358

Drug Name

ACETYLCYSTEINE

Product Number

1

Dosage Form

-

Strength

6GM/30ML (200MG/ML)

Approval Date

2016-02-29

207358 / 1

Active Ingredient

ACETYLCYSTEINE

Application Number

207358

Product Number

1

Dosage Form

-

Strength

6GM/30ML (200MG/ML)

Approval Date

2016-02-29

Regulatory Status

RX

2013
11 Oct
RX Application: 203701

Drug Name

ACYCLOVIR SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

2013-10-11

203701 / 1

Active Ingredient

ACYCLOVIR SODIUM

Application Number

203701

Product Number

1

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

2013-10-11

Regulatory Status

RX

2017
02 Nov
RX Application: 205331

Drug Name

ADENOSINE

Product Number

1

Dosage Form

-

Strength

60MG/20ML (3MG/ML)

Approval Date

2017-11-02

205331 / 1

Active Ingredient

ADENOSINE

Application Number

205331

Product Number

1

Dosage Form

-

Strength

60MG/20ML (3MG/ML)

Approval Date

2017-11-02

Regulatory Status

RX

2017
02 Nov
RX Application: 205331

Drug Name

ADENOSINE

Product Number

2

Dosage Form

-

Strength

90MG/30ML (3MG/ML)

Approval Date

2017-11-02

205331 / 2

Active Ingredient

ADENOSINE

Application Number

205331

Product Number

2

Dosage Form

-

Strength

90MG/30ML (3MG/ML)

Approval Date

2017-11-02

Regulatory Status

RX

2023
23 Jun
Discontinued Application: 210659

Drug Name

ALCAFTADINE

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

2023-06-23

210659 / 1

Active Ingredient

ALCAFTADINE

Application Number

210659

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

2023-06-23

Regulatory Status

Discontinued

2017
25 Oct
Discontinued Application: 204550

Drug Name

AMIODARONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2017-10-25

204550 / 1

Active Ingredient

AMIODARONE HYDROCHLORIDE

Application Number

204550

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2017-10-25

Regulatory Status

Discontinued

2022
17 Nov
RX Application: 214010

Drug Name

AMPHOTERICIN B

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2022-11-17

214010 / 1

Active Ingredient

AMPHOTERICIN B

Application Number

214010

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2022-11-17

Regulatory Status

RX

2020
24 Jul
RX Application: 212434

Drug Name

ANASTROZOLE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2020-07-24

212434 / 1

Active Ingredient

ANASTROZOLE

Application Number

212434

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2020-07-24

Regulatory Status

RX

2021
15 Oct
Discontinued Application: 214011

Drug Name

ARSENIC TRIOXIDE

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2021-10-15

214011 / 1

Active Ingredient

ARSENIC TRIOXIDE

Application Number

214011

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2021-10-15

Regulatory Status

Discontinued

2015
08 Apr
Discontinued Application: 206011

Drug Name

ATRACURIUM BESYLATE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2015-04-08

206011 / 1

Active Ingredient

ATRACURIUM BESYLATE

Application Number

206011

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2015-04-08

Regulatory Status

Discontinued

2015
08 Apr
Discontinued Application: 206010

Drug Name

ATRACURIUM BESYLATE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2015-04-08

206010 / 1

Active Ingredient

ATRACURIUM BESYLATE

Application Number

206010

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2015-04-08

Regulatory Status

Discontinued

2022
30 Dec
RX Application: 215066

Drug Name

AZACITIDINE

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2022-12-30

215066 / 1

Active Ingredient

AZACITIDINE

Application Number

215066

Product Number

1

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2022-12-30

Regulatory Status

RX

2015
19 Jun
RX Application: 203294

Drug Name

AZITHROMYCIN

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2015-06-19

203294 / 1

Active Ingredient

AZITHROMYCIN

Application Number

203294

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2015-06-19

Regulatory Status

RX

2023
05 Jun
RX Application: 214739

Drug Name

BENDAMUSTINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG/VIAL

Approval Date

2023-06-05

214739 / 1

Active Ingredient

BENDAMUSTINE HYDROCHLORIDE

Application Number

214739

Product Number

1

Dosage Form

-

Strength

25MG/VIAL

Approval Date

2023-06-05

Regulatory Status

RX

2023
05 Jun
RX Application: 214739

Drug Name

BENDAMUSTINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2023-06-05

214739 / 2

Active Ingredient

BENDAMUSTINE HYDROCHLORIDE

Application Number

214739

Product Number

2

Dosage Form

-

Strength

100MG/VIAL

Approval Date

2023-06-05

Regulatory Status

RX

2022
06 Oct
RX Application: 205537

Drug Name

BIMATOPROST

Product Number

1

Dosage Form

-

Strength

0.03%

Approval Date

2022-10-06

205537 / 1

Active Ingredient

BIMATOPROST

Application Number

205537

Product Number

1

Dosage Form

-

Strength

0.03%

Approval Date

2022-10-06

Regulatory Status

RX

2018
27 Jul
Discontinued Application: 205962

Drug Name

BIVALIRUDIN

Product Number

1

Dosage Form

-

Strength

250MG/VIAL

Approval Date

2018-07-27

205962 / 1

Active Ingredient

BIVALIRUDIN

Application Number

205962

Product Number

1

Dosage Form

-

Strength

250MG/VIAL

Approval Date

2018-07-27

Regulatory Status

Discontinued

2022
02 May
RX Application: 212825

Drug Name

BORTEZOMIB

Product Number

1

Dosage Form

-

Strength

3.5MG/VIAL

Approval Date

2022-05-02

212825 / 1

Active Ingredient

BORTEZOMIB

Application Number

212825

Product Number

1

Dosage Form

-

Strength

3.5MG/VIAL

Approval Date

2022-05-02

Regulatory Status

RX

2022
18 Mar
RX Application: 204813

Drug Name

BROMFENAC SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 0.09% ACID

Approval Date

2022-03-18

204813 / 1

Active Ingredient

BROMFENAC SODIUM

Application Number

204813

Product Number

1

Dosage Form

-

Strength

EQ 0.09% ACID

Approval Date

2022-03-18

Regulatory Status

RX

2023
29 Nov
RX Application: 216667

Drug Name

BUDESONIDE

Product Number

1

Dosage Form

-

Strength

0.5MG/2ML

Approval Date

2023-11-29

216667 / 1

Active Ingredient

BUDESONIDE

Application Number

216667

Product Number

1

Dosage Form

-

Strength

0.5MG/2ML

Approval Date

2023-11-29

Regulatory Status

RX

2016
13 May
RX Application: 207183

Drug Name

BUPIVACAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

2016-05-13

207183 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

207183

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

2016-05-13

Regulatory Status

RX

2016
13 May
RX Application: 207183

Drug Name

BUPIVACAINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

0.5%

Approval Date

2016-05-13

207183 / 2

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

207183

Product Number

2

Dosage Form

-

Strength

0.5%

Approval Date

2016-05-13

Regulatory Status

RX

2013
05 Nov
RX Application: 203895

Drug Name

BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

2013-11-05

203895 / 1

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

203895

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

2013-11-05

Regulatory Status

RX

2013
05 Nov
RX Application: 203895

Drug Name

BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE

Product Number

2

Dosage Form

-

Strength

0.5%

Approval Date

2013-11-05

203895 / 2

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

203895

Product Number

2

Dosage Form

-

Strength

0.5%

Approval Date

2013-11-05

Regulatory Status

RX

2013
05 Nov
RX Application: 203895

Drug Name

BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE

Product Number

3

Dosage Form

-

Strength

0.75%

Approval Date

2013-11-05

203895 / 3

Active Ingredient

BUPIVACAINE HYDROCHLORIDE

Application Number

203895

Product Number

3

Dosage Form

-

Strength

0.75%

Approval Date

2013-11-05

Regulatory Status

RX

2024
25 Jun
Discontinued Application: 215102

Drug Name

BUSULFAN

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2024-06-25

215102 / 1

Active Ingredient

BUSULFAN

Application Number

215102

Product Number

1

Dosage Form

-

Strength

6MG/ML

Approval Date

2024-06-25

Regulatory Status

Discontinued

2015
22 Sep
Discontinued Application: 205013

Drug Name

CAFFEINE CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date

2015-09-22

205013 / 1

Active Ingredient

CAFFEINE CITRATE

Application Number

205013

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date

2015-09-22

Regulatory Status

Discontinued

2018
17 Apr
RX Application: 210604

Drug Name

CAPECITABINE

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2018-04-17

210604 / 1

Active Ingredient

CAPECITABINE

Application Number

210604

Product Number

1

Dosage Form

-

Strength

150MG

Approval Date

2018-04-17

Regulatory Status

RX

2018
17 Apr
RX Application: 210604

Drug Name

CAPECITABINE

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2018-04-17

210604 / 2

Active Ingredient

CAPECITABINE

Application Number

210604

Product Number

2

Dosage Form

-

Strength

500MG

Approval Date

2018-04-17

Regulatory Status

RX

2016
28 Mar
RX Application: 205487

Drug Name

CARBOPLATIN

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2016-03-28

205487 / 1

Active Ingredient

CARBOPLATIN

Application Number

205487

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2016-03-28

Regulatory Status

RX

2016
28 Mar
RX Application: 205487

Drug Name

CARBOPLATIN

Product Number

2

Dosage Form

-

Strength

150MG/15ML (10MG/ML)

Approval Date

2016-03-28

205487 / 2

Active Ingredient

CARBOPLATIN

Application Number

205487

Product Number

2

Dosage Form

-

Strength

150MG/15ML (10MG/ML)

Approval Date

2016-03-28

Regulatory Status

RX

2016
28 Mar
RX Application: 205487

Drug Name

CARBOPLATIN

Product Number

3

Dosage Form

-

Strength

450MG/45ML (10MG/ML)

Approval Date

2016-03-28

205487 / 3

Active Ingredient

CARBOPLATIN

Application Number

205487

Product Number

3

Dosage Form

-

Strength

450MG/45ML (10MG/ML)

Approval Date

2016-03-28

Regulatory Status

RX

2020
03 Aug
RX Application: 205487

Drug Name

CARBOPLATIN

Product Number

4

Dosage Form

-

Strength

600MG/60ML (10MG/ML)

Approval Date

2020-08-03

205487 / 4

Active Ingredient

CARBOPLATIN

Application Number

205487

Product Number

4

Dosage Form

-

Strength

600MG/60ML (10MG/ML)

Approval Date

2020-08-03

Regulatory Status

RX

2023
25 May
RX Application: 216939

Drug Name

CARBOPROST TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE/ML

Approval Date

2023-05-25

216939 / 1

Active Ingredient

CARBOPROST TROMETHAMINE

Application Number

216939

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE/ML

Approval Date

2023-05-25

Regulatory Status

RX

-
Unclassified Application: 210823

Drug Name

CARFILZOMIB

Product Number

1

Dosage Form

-

Strength

60MG/VIAL

Approval Date

-

210823 / 1

Active Ingredient

CARFILZOMIB

Application Number

210823

Product Number

1

Dosage Form

-

Strength

60MG/VIAL

Approval Date

-

Regulatory Status

Unclassified

2020
07 Jul
RX Application: 211816

Drug Name

CHLORPROMAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

2020-07-07

211816 / 1

Active Ingredient

CHLORPROMAZINE HYDROCHLORIDE

Application Number

211816

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

2020-07-07

Regulatory Status

RX

2020
08 May
Discontinued Application: 209144

Drug Name

CISATRACURIUM BESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2020-05-08

209144 / 1

Active Ingredient

CISATRACURIUM BESYLATE

Application Number

209144

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2020-05-08

Regulatory Status

Discontinued

2020
27 Oct
Discontinued Application: 209665

Drug Name

CISATRACURIUM BESYLATE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2020-10-27

209665 / 1

Active Ingredient

CISATRACURIUM BESYLATE

Application Number

209665

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2020-10-27

Regulatory Status

Discontinued

2022
03 Oct
Discontinued Application: 212457

Drug Name

CLOFARABINE

Product Number

1

Dosage Form

-

Strength

20MG/20ML (1MG/ML)

Approval Date

2022-10-03

212457 / 1

Active Ingredient

CLOFARABINE

Application Number

212457

Product Number

1

Dosage Form

-

Strength

20MG/20ML (1MG/ML)

Approval Date

2022-10-03

Regulatory Status

Discontinued

1994
26 Apr
Discontinued Application: 74209

Drug Name

CROMOLYN SODIUM

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1994-04-26

74209 / 1

Active Ingredient

CROMOLYN SODIUM

Application Number

74209

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

1994-04-26

Regulatory Status

Discontinued

2020
08 Dec
RX Application: 213874

Drug Name

CYANOCOBALAMIN

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2020-12-08

213874 / 1

Active Ingredient

CYANOCOBALAMIN

Application Number

213874

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2020-12-08

Regulatory Status

RX

2017
09 Nov
RX Application: 203385

Drug Name

DACTINOMYCIN

Product Number

1

Dosage Form

-

Strength

0.5MG/VIAL

Approval Date

2017-11-09

203385 / 1

Active Ingredient

DACTINOMYCIN

Application Number

203385

Product Number

1

Dosage Form

-

Strength

0.5MG/VIAL

Approval Date

2017-11-09

Regulatory Status

RX

2021
02 Sep
RX Application: 213171

Drug Name

DAPTOMYCIN

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2021-09-02

213171 / 1

Active Ingredient

DAPTOMYCIN

Application Number

213171

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2021-09-02

Regulatory Status

RX

2025
22 Apr
RX Application: 216547

Drug Name

DASATINIB

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2025-04-22

216547 / 1

Active Ingredient

DASATINIB

Application Number

216547

Product Number

1

Dosage Form

-

Strength

20MG

Approval Date

2025-04-22

Regulatory Status

RX

2025
22 Apr
RX Application: 216547

Drug Name

DASATINIB

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2025-04-22

216547 / 2

Active Ingredient

DASATINIB

Application Number

216547

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2025-04-22

Regulatory Status

RX

2025
22 Apr
RX Application: 216547

Drug Name

DASATINIB

Product Number

3

Dosage Form

-

Strength

70MG

Approval Date

2025-04-22

216547 / 3

Active Ingredient

DASATINIB

Application Number

216547

Product Number

3

Dosage Form

-

Strength

70MG

Approval Date

2025-04-22

Regulatory Status

RX

2025
22 Apr
RX Application: 216547

Drug Name

DASATINIB

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

2025-04-22

216547 / 4

Active Ingredient

DASATINIB

Application Number

216547

Product Number

4

Dosage Form

-

Strength

80MG

Approval Date

2025-04-22

Regulatory Status

RX

2025
22 Apr
RX Application: 216547

Drug Name

DASATINIB

Product Number

5

Dosage Form

-

Strength

100MG

Approval Date

2025-04-22

216547 / 5

Active Ingredient

DASATINIB

Application Number

216547

Product Number

5

Dosage Form

-

Strength

100MG

Approval Date

2025-04-22

Regulatory Status

RX

2025
22 Apr
RX Application: 216547

Drug Name

DASATINIB

Product Number

6

Dosage Form

-

Strength

140MG

Approval Date

2025-04-22

216547 / 6

Active Ingredient

DASATINIB

Application Number

216547

Product Number

6

Dosage Form

-

Strength

140MG

Approval Date

2025-04-22

Regulatory Status

RX

2021
20 Sep
Discontinued Application: 214569

Drug Name

DECITABINE

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2021-09-20

214569 / 1

Active Ingredient

DECITABINE

Application Number

214569

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2021-09-20

Regulatory Status

Discontinued

2015
01 Dec
Discontinued Application: 206781

Drug Name

DEXAMETHASONE SODIUM PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 4MG PHOSPHATE/ML

Approval Date

2015-12-01

206781 / 1

Active Ingredient

DEXAMETHASONE SODIUM PHOSPHATE

Application Number

206781

Product Number

1

Dosage Form

-

Strength

EQ 4MG PHOSPHATE/ML

Approval Date

2015-12-01

Regulatory Status

Discontinued

2020
05 Jun
RX Application: 210966

Drug Name

DEXAMETHASONE SODIUM PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG PHOSPHATE/ML

Approval Date

2020-06-05

210966 / 1

Active Ingredient

DEXAMETHASONE SODIUM PHOSPHATE

Application Number

210966

Product Number

1

Dosage Form

-

Strength

EQ 10MG PHOSPHATE/ML

Approval Date

2020-06-05

Regulatory Status

RX

2019
07 Jun
Discontinued Application: 210967

Drug Name

DEXAMETHASONE SODIUM PHOSPHATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG PHOSPHATE/ML

Approval Date

2019-06-07

210967 / 1

Active Ingredient

DEXAMETHASONE SODIUM PHOSPHATE

Application Number

210967

Product Number

1

Dosage Form

-

Strength

EQ 10MG PHOSPHATE/ML

Approval Date

2019-06-07

Regulatory Status

Discontinued

2016
17 Mar
RX Application: 205867

Drug Name

DEXMEDETOMIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)

Approval Date

2016-03-17

205867 / 1

Active Ingredient

DEXMEDETOMIDINE HYDROCHLORIDE

Application Number

205867

Product Number

1

Dosage Form

-

Strength

EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)

Approval Date

2016-03-17

Regulatory Status

RX

2020
07 Dec
RX Application: 210321

Drug Name

DEXMEDETOMIDINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)

Approval Date

2020-12-07

210321 / 1

Active Ingredient

DEXMEDETOMIDINE HYDROCHLORIDE

Application Number

210321

Product Number

1

Dosage Form

-

Strength

EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)

Approval Date

2020-12-07

Regulatory Status

RX

2020
07 Dec
RX Application: 210321

Drug Name

DEXMEDETOMIDINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)

Approval Date

2020-12-07

210321 / 2

Active Ingredient

DEXMEDETOMIDINE HYDROCHLORIDE

Application Number

210321

Product Number

2

Dosage Form

-

Strength

EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)

Approval Date

2020-12-07

Regulatory Status

RX

2011
19 Oct
RX Application: 200752

Drug Name

DEXRAZOXANE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

2011-10-19

200752 / 1

Active Ingredient

DEXRAZOXANE HYDROCHLORIDE

Application Number

200752

Product Number

1

Dosage Form

-

Strength

EQ 250MG BASE/VIAL

Approval Date

2011-10-19

Regulatory Status

RX

2011
19 Oct
RX Application: 200752

Drug Name

DEXRAZOXANE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2011-10-19

200752 / 2

Active Ingredient

DEXRAZOXANE HYDROCHLORIDE

Application Number

200752

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2011-10-19

Regulatory Status

RX

2023
29 Mar
Discontinued Application: 216552

Drug Name

DILTIAZEM HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

2023-03-29

216552 / 1

Active Ingredient

DILTIAZEM HYDROCHLORIDE

Application Number

216552

Product Number

1

Dosage Form

-

Strength

5MG/ML

Approval Date

2023-03-29

Regulatory Status

Discontinued

2021
25 Jun
Discontinued Application: 214575

Drug Name

DOCETAXEL

Product Number

1

Dosage Form

-

Strength

20MG/2ML (10MG/ML)

Approval Date

2021-06-25

214575 / 1

Active Ingredient

DOCETAXEL

Application Number

214575

Product Number

1

Dosage Form

-

Strength

20MG/2ML (10MG/ML)

Approval Date

2021-06-25

Regulatory Status

Discontinued

2021
25 Jun
Discontinued Application: 214575

Drug Name

DOCETAXEL

Product Number

2

Dosage Form

-

Strength

80MG/8ML (10MG/ML)

Approval Date

2021-06-25

214575 / 2

Active Ingredient

DOCETAXEL

Application Number

214575

Product Number

2

Dosage Form

-

Strength

80MG/8ML (10MG/ML)

Approval Date

2021-06-25

Regulatory Status

Discontinued

2021
25 Jun
Discontinued Application: 214575

Drug Name

DOCETAXEL

Product Number

3

Dosage Form

-

Strength

160MG/16ML (10MG/ML)

Approval Date

2021-06-25

214575 / 3

Active Ingredient

DOCETAXEL

Application Number

214575

Product Number

3

Dosage Form

-

Strength

160MG/16ML (10MG/ML)

Approval Date

2021-06-25

Regulatory Status

Discontinued

2021
14 May
RX Application: 207629

Drug Name

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE;EQ 0.5% BASE

Approval Date

2021-05-14

207629 / 1

Active Ingredient

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

Application Number

207629

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE;EQ 0.5% BASE

Approval Date

2021-05-14

Regulatory Status

RX

2018
24 Jul
RX Application: 207630

Drug Name

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE;EQ 0.5% BASE

Approval Date

2018-07-24

207630 / 1

Active Ingredient

DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE

Application Number

207630

Product Number

1

Dosage Form

-

Strength

EQ 2% BASE;EQ 0.5% BASE

Approval Date

2018-07-24

Regulatory Status

RX

2022
24 Jan
Discontinued Application: 213717

Drug Name

DOXERCALCIFEROL

Product Number

1

Dosage Form

-

Strength

2MCG/ML (2MCG/ML)

Approval Date

2022-01-24

213717 / 1

Active Ingredient

DOXERCALCIFEROL

Application Number

213717

Product Number

1

Dosage Form

-

Strength

2MCG/ML (2MCG/ML)

Approval Date

2022-01-24

Regulatory Status

Discontinued

2022
24 Jan
Discontinued Application: 213717

Drug Name

DOXERCALCIFEROL

Product Number

2

Dosage Form

-

Strength

4MCG/2ML (2MCG/ML)

Approval Date

2022-01-24

213717 / 2

Active Ingredient

DOXERCALCIFEROL

Application Number

213717

Product Number

2

Dosage Form

-

Strength

4MCG/2ML (2MCG/ML)

Approval Date

2022-01-24

Regulatory Status

Discontinued

2021
14 Jun
RX Application: 214579

Drug Name

EPHEDRINE SULFATE

Product Number

1

Dosage Form

-

Strength

50MG/ML (50MG/ML)

Approval Date

2021-06-14

214579 / 1

Active Ingredient

EPHEDRINE SULFATE

Application Number

214579

Product Number

1

Dosage Form

-

Strength

50MG/ML (50MG/ML)

Approval Date

2021-06-14

Regulatory Status

RX

2015
08 Dec
RX Application: 206127

Drug Name

EPTIFIBATIDE

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2015-12-08

206127 / 1

Active Ingredient

EPTIFIBATIDE

Application Number

206127

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2015-12-08

Regulatory Status

RX

2015
08 Dec
RX Application: 206127

Drug Name

EPTIFIBATIDE

Product Number

2

Dosage Form

-

Strength

75MG/100ML

Approval Date

2015-12-08

206127 / 2

Active Ingredient

EPTIFIBATIDE

Application Number

206127

Product Number

2

Dosage Form

-

Strength

75MG/100ML

Approval Date

2015-12-08

Regulatory Status

RX

2022
22 Jun
Discontinued Application: 216342

Drug Name

ERLOTINIB HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2022-06-22

216342 / 1

Active Ingredient

ERLOTINIB HYDROCHLORIDE

Application Number

216342

Product Number

1

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2022-06-22

Regulatory Status

Discontinued

2022
22 Jun
Discontinued Application: 216342

Drug Name

ERLOTINIB HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2022-06-22

216342 / 2

Active Ingredient

ERLOTINIB HYDROCHLORIDE

Application Number

216342

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2022-06-22

Regulatory Status

Discontinued

2022
22 Jun
Discontinued Application: 216342

Drug Name

ERLOTINIB HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2022-06-22

216342 / 3

Active Ingredient

ERLOTINIB HYDROCHLORIDE

Application Number

216342

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2022-06-22

Regulatory Status

Discontinued

2018
25 Jun
RX Application: 209133

Drug Name

ERTAPENEM SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2018-06-25

209133 / 1

Active Ingredient

ERTAPENEM SODIUM

Application Number

209133

Product Number

1

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2018-06-25

Regulatory Status

RX

2015
23 Jul
RX Application: 205520

Drug Name

ESMOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2015-07-23

205520 / 1

Active Ingredient

ESMOLOL HYDROCHLORIDE

Application Number

205520

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2015-07-23

Regulatory Status

RX

2022
21 Mar
RX Application: 216244

Drug Name

ESMOLOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1GM/100ML

Approval Date

2022-03-21

216244 / 1

Active Ingredient

ESMOLOL HYDROCHLORIDE

Application Number

216244

Product Number

1

Dosage Form

-

Strength

1GM/100ML

Approval Date

2022-03-21

Regulatory Status

RX

2022
21 Mar
RX Application: 216244

Drug Name

ESMOLOL HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

2GM/100ML

Approval Date

2022-03-21

216244 / 2

Active Ingredient

ESMOLOL HYDROCHLORIDE

Application Number

216244

Product Number

2

Dosage Form

-

Strength

2GM/100ML

Approval Date

2022-03-21

Regulatory Status

RX

2016
10 Aug
Discontinued Application: 204657

Drug Name

ESOMEPRAZOLE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/VIAL

Approval Date

2016-08-10

204657 / 1

Active Ingredient

ESOMEPRAZOLE SODIUM

Application Number

204657

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/VIAL

Approval Date

2016-08-10

Regulatory Status

Discontinued

2016
10 Aug
Discontinued Application: 204657

Drug Name

ESOMEPRAZOLE SODIUM

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

2016-08-10

204657 / 2

Active Ingredient

ESOMEPRAZOLE SODIUM

Application Number

204657

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

2016-08-10

Regulatory Status

Discontinued

2017
24 Feb
RX Application: 206126

Drug Name

ETOMIDATE

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2017-02-24

206126 / 1

Active Ingredient

ETOMIDATE

Application Number

206126

Product Number

1

Dosage Form

-

Strength

2MG/ML

Approval Date

2017-02-24

Regulatory Status

RX

2026
25 Feb
RX Application: 219533

Drug Name

EVEROLIMUS

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2026-02-25

219533 / 1

Active Ingredient

EVEROLIMUS

Application Number

219533

Product Number

1

Dosage Form

-

Strength

0.25MG

Approval Date

2026-02-25

Regulatory Status

RX

2026
25 Feb
RX Application: 219533

Drug Name

EVEROLIMUS

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2026-02-25

219533 / 2

Active Ingredient

EVEROLIMUS

Application Number

219533

Product Number

2

Dosage Form

-

Strength

0.5MG

Approval Date

2026-02-25

Regulatory Status

RX

2026
25 Feb
RX Application: 219533

Drug Name

EVEROLIMUS

Product Number

3

Dosage Form

-

Strength

0.75MG

Approval Date

2026-02-25

219533 / 3

Active Ingredient

EVEROLIMUS

Application Number

219533

Product Number

3

Dosage Form

-

Strength

0.75MG

Approval Date

2026-02-25

Regulatory Status

RX

2026
25 Feb
RX Application: 219533

Drug Name

EVEROLIMUS

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

2026-02-25

219533 / 4

Active Ingredient

EVEROLIMUS

Application Number

219533

Product Number

4

Dosage Form

-

Strength

1MG

Approval Date

2026-02-25

Regulatory Status

RX

2022
20 May
RX Application: 216454

Drug Name

EXEMESTANE

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2022-05-20

216454 / 1

Active Ingredient

EXEMESTANE

Application Number

216454

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2022-05-20

Regulatory Status

RX

2017
17 Oct
RX Application: 207739

Drug Name

FLUPHENAZINE DECANOATE

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

2017-10-17

207739 / 1

Active Ingredient

FLUPHENAZINE DECANOATE

Application Number

207739

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

2017-10-17

Regulatory Status

RX

2017
26 Dec
RX Application: 206918

Drug Name

FONDAPARINUX SODIUM

Product Number

1

Dosage Form

-

Strength

2.5MG/0.5ML (2.5MG/0.5ML)

Approval Date

2017-12-26

206918 / 1

Active Ingredient

FONDAPARINUX SODIUM

Application Number

206918

Product Number

1

Dosage Form

-

Strength

2.5MG/0.5ML (2.5MG/0.5ML)

Approval Date

2017-12-26

Regulatory Status

RX

2017
26 Dec
RX Application: 206918

Drug Name

FONDAPARINUX SODIUM

Product Number

2

Dosage Form

-

Strength

5MG/0.4ML (5MG/0.4ML)

Approval Date

2017-12-26

206918 / 2

Active Ingredient

FONDAPARINUX SODIUM

Application Number

206918

Product Number

2

Dosage Form

-

Strength

5MG/0.4ML (5MG/0.4ML)

Approval Date

2017-12-26

Regulatory Status

RX

2017
26 Dec
RX Application: 206918

Drug Name

FONDAPARINUX SODIUM

Product Number

3

Dosage Form

-

Strength

7.5MG/0.6ML (7.5MG/0.6ML)

Approval Date

2017-12-26

206918 / 3

Active Ingredient

FONDAPARINUX SODIUM

Application Number

206918

Product Number

3

Dosage Form

-

Strength

7.5MG/0.6ML (7.5MG/0.6ML)

Approval Date

2017-12-26

Regulatory Status

RX

2017
26 Dec
RX Application: 206918

Drug Name

FONDAPARINUX SODIUM

Product Number

4

Dosage Form

-

Strength

10MG/0.8ML (10MG/0.8ML)

Approval Date

2017-12-26

206918 / 4

Active Ingredient

FONDAPARINUX SODIUM

Application Number

206918

Product Number

4

Dosage Form

-

Strength

10MG/0.8ML (10MG/0.8ML)

Approval Date

2017-12-26

Regulatory Status

RX

2021
12 Jan
RX Application: 210625

Drug Name

FOSAPREPITANT DIMEGLUMINE

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE/VIAL

Approval Date

2021-01-12

210625 / 1

Active Ingredient

FOSAPREPITANT DIMEGLUMINE

Application Number

210625

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE/VIAL

Approval Date

2021-01-12

Regulatory Status

RX

2019
23 Jul
Discontinued Application: 208811

Drug Name

FULVESTRANT

Product Number

1

Dosage Form

-

Strength

250MG/5ML (50MG/ML)

Approval Date

2019-07-23

208811 / 1

Active Ingredient

FULVESTRANT

Application Number

208811

Product Number

1

Dosage Form

-

Strength

250MG/5ML (50MG/ML)

Approval Date

2019-07-23

Regulatory Status

Discontinued

2023
30 Jun
Discontinued Application: 215169

Drug Name

FULVESTRANT

Product Number

1

Dosage Form

-

Strength

250MG/5ML (50MG/ML)

Approval Date

2023-06-30

215169 / 1

Active Ingredient

FULVESTRANT

Application Number

215169

Product Number

1

Dosage Form

-

Strength

250MG/5ML (50MG/ML)

Approval Date

2023-06-30

Regulatory Status

Discontinued

2019
03 May
RX Application: 212174

Drug Name

FUROSEMIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2019-05-03

212174 / 1

Active Ingredient

FUROSEMIDE

Application Number

212174

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2019-05-03

Regulatory Status

RX

2024
08 Jan
Discontinued Application: 215236

Drug Name

GENTAMICIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2024-01-08

215236 / 1

Active Ingredient

GENTAMICIN SULFATE

Application Number

215236

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2024-01-08

Regulatory Status

Discontinued

2024
08 Jan
RX Application: 215237

Drug Name

GENTAMICIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

2024-01-08

215237 / 1

Active Ingredient

GENTAMICIN SULFATE

Application Number

215237

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/ML

Approval Date

2024-01-08

Regulatory Status

RX

2018
28 Nov
Discontinued Application: 210244

Drug Name

GLYCOPYRROLATE

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

2018-11-28

210244 / 1

Active Ingredient

GLYCOPYRROLATE

Application Number

210244

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

2018-11-28

Regulatory Status

Discontinued

2016
06 Jul
Discontinued Application: 204238

Drug Name

GRANISETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML (EQ 1MG BASE/ML)

Approval Date

2016-07-06

204238 / 1

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

204238

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE/ML (EQ 1MG BASE/ML)

Approval Date

2016-07-06

Regulatory Status

Discontinued

2016
06 Jul
Discontinued Application: 204238

Drug Name

GRANISETRON HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

Approval Date

2016-07-06

204238 / 2

Active Ingredient

GRANISETRON HYDROCHLORIDE

Application Number

204238

Product Number

2

Dosage Form

-

Strength

EQ 4MG BASE/4ML (EQ 1MG BASE/ML)

Approval Date

2016-07-06

Regulatory Status

Discontinued

2023
13 Feb
RX Application: 215147

Drug Name

HYDRALAZINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

2023-02-13

215147 / 1

Active Ingredient

HYDRALAZINE HYDROCHLORIDE

Application Number

215147

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

2023-02-13

Regulatory Status

RX

2019
09 May
Discontinued Application: 211142

Drug Name

HYDROXYPROGESTERONE CAPROATE

Product Number

1

Dosage Form

-

Strength

1250MG/5ML (250MG/ML)

Approval Date

2019-05-09

211142 / 1

Active Ingredient

HYDROXYPROGESTERONE CAPROATE

Application Number

211142

Product Number

1

Dosage Form

-

Strength

1250MG/5ML (250MG/ML)

Approval Date

2019-05-09

Regulatory Status

Discontinued

2015
19 Aug
RX Application: 205332

Drug Name

IBANDRONATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 3MG BASE/3ML

Approval Date

2015-08-19

205332 / 1

Active Ingredient

IBANDRONATE SODIUM

Application Number

205332

Product Number

1

Dosage Form

-

Strength

EQ 3MG BASE/3ML

Approval Date

2015-08-19

Regulatory Status

RX

2023
14 Aug
RX Application: 213521

Drug Name

ICATIBANT ACETATE

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date

2023-08-14

213521 / 1

Active Ingredient

ICATIBANT ACETATE

Application Number

213521

Product Number

1

Dosage Form

-

Strength

EQ 30MG BASE/3ML (EQ 10MG BASE/ML)

Approval Date

2023-08-14

Regulatory Status

RX

2020
23 Jul
RX Application: 212773

Drug Name

IMATINIB MESYLATE

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2020-07-23

212773 / 1

Active Ingredient

IMATINIB MESYLATE

Application Number

212773

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

2020-07-23

Regulatory Status

RX

2020
23 Jul
RX Application: 212773

Drug Name

IMATINIB MESYLATE

Product Number

2

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2020-07-23

212773 / 2

Active Ingredient

IMATINIB MESYLATE

Application Number

212773

Product Number

2

Dosage Form

-

Strength

EQ 400MG BASE

Approval Date

2020-07-23

Regulatory Status

RX

2020
02 Nov
RX Application: 213278

Drug Name

IRINOTECAN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

40MG/2ML (20MG/ML)

Approval Date

2020-11-02

213278 / 1

Active Ingredient

IRINOTECAN HYDROCHLORIDE

Application Number

213278

Product Number

1

Dosage Form

-

Strength

40MG/2ML (20MG/ML)

Approval Date

2020-11-02

Regulatory Status

RX

2020
02 Nov
RX Application: 213278

Drug Name

IRINOTECAN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG/5ML (20MG/ML)

Approval Date

2020-11-02

213278 / 2

Active Ingredient

IRINOTECAN HYDROCHLORIDE

Application Number

213278

Product Number

2

Dosage Form

-

Strength

100MG/5ML (20MG/ML)

Approval Date

2020-11-02

Regulatory Status

RX

2020
02 Nov
RX Application: 213278

Drug Name

IRINOTECAN HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

300MG/15ML (20MG/ML)

Approval Date

2020-11-02

213278 / 3

Active Ingredient

IRINOTECAN HYDROCHLORIDE

Application Number

213278

Product Number

3

Dosage Form

-

Strength

300MG/15ML (20MG/ML)

Approval Date

2020-11-02

Regulatory Status

RX

2022
11 Apr
RX Application: 213278

Drug Name

IRINOTECAN HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

500MG/25ML (20MG/ML)

Approval Date

2022-04-11

213278 / 4

Active Ingredient

IRINOTECAN HYDROCHLORIDE

Application Number

213278

Product Number

4

Dosage Form

-

Strength

500MG/25ML (20MG/ML)

Approval Date

2022-04-11

Regulatory Status

RX

2021
09 Feb
Discontinued Application: 211864

Drug Name

ISOPROTERENOL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

2021-02-09

211864 / 1

Active Ingredient

ISOPROTERENOL HYDROCHLORIDE

Application Number

211864

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

2021-02-09

Regulatory Status

Discontinued

2016
02 Feb
RX Application: 206831

Drug Name

ISOSULFAN BLUE

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2016-02-02

206831 / 1

Active Ingredient

ISOSULFAN BLUE

Application Number

206831

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2016-02-02

Regulatory Status

RX

2008
30 Sep
RX Application: 76092

Drug Name

KETAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2008-09-30

76092 / 1

Active Ingredient

KETAMINE HYDROCHLORIDE

Application Number

76092

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/ML

Approval Date

2008-09-30

Regulatory Status

RX

2001
28 Dec
RX Application: 76092

Drug Name

KETAMINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

2001-12-28

76092 / 2

Active Ingredient

KETAMINE HYDROCHLORIDE

Application Number

76092

Product Number

2

Dosage Form

-

Strength

EQ 50MG BASE/ML

Approval Date

2001-12-28

Regulatory Status

RX

2002
25 Oct
RX Application: 76092

Drug Name

KETAMINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

2002-10-25

76092 / 3

Active Ingredient

KETAMINE HYDROCHLORIDE

Application Number

76092

Product Number

3

Dosage Form

-

Strength

EQ 100MG BASE/ML

Approval Date

2002-10-25

Regulatory Status

RX

2020
03 Dec
Discontinued Application: 205190

Drug Name

KETOROLAC TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2020-12-03

205190 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

205190

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2020-12-03

Regulatory Status

Discontinued

2018
15 Nov
Discontinued Application: 205191

Drug Name

KETOROLAC TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

0.4%

Approval Date

2018-11-15

205191 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

205191

Product Number

1

Dosage Form

-

Strength

0.4%

Approval Date

2018-11-15

Regulatory Status

Discontinued

2020
20 Oct
Discontinued Application: 212939

Drug Name

KETOROLAC TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

15MG/ML

Approval Date

2020-10-20

212939 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

212939

Product Number

1

Dosage Form

-

Strength

15MG/ML

Approval Date

2020-10-20

Regulatory Status

Discontinued

2020
20 Oct
Discontinued Application: 212939

Drug Name

KETOROLAC TROMETHAMINE

Product Number

2

Dosage Form

-

Strength

30MG/ML

Approval Date

2020-10-20

212939 / 2

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

212939

Product Number

2

Dosage Form

-

Strength

30MG/ML

Approval Date

2020-10-20

Regulatory Status

Discontinued

2019
03 Sep
Discontinued Application: 206519

Drug Name

LATANOPROST

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

2019-09-03

206519 / 1

Active Ingredient

LATANOPROST

Application Number

206519

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

2019-09-03

Regulatory Status

Discontinued

2023
06 Mar
RX Application: 213885

Drug Name

LENALIDOMIDE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2023-03-06

213885 / 1

Active Ingredient

LENALIDOMIDE

Application Number

213885

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2023-03-06

Regulatory Status

RX

2023
06 Mar
RX Application: 213885

Drug Name

LENALIDOMIDE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2023-03-06

213885 / 2

Active Ingredient

LENALIDOMIDE

Application Number

213885

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2023-03-06

Regulatory Status

RX

2023
06 Mar
RX Application: 213885

Drug Name

LENALIDOMIDE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2023-03-06

213885 / 3

Active Ingredient

LENALIDOMIDE

Application Number

213885

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2023-03-06

Regulatory Status

RX

2023
06 Mar
RX Application: 213885

Drug Name

LENALIDOMIDE

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2023-03-06

213885 / 4

Active Ingredient

LENALIDOMIDE

Application Number

213885

Product Number

4

Dosage Form

-

Strength

15MG

Approval Date

2023-03-06

Regulatory Status

RX

2023
06 Mar
RX Application: 213885

Drug Name

LENALIDOMIDE

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2023-03-06

213885 / 5

Active Ingredient

LENALIDOMIDE

Application Number

213885

Product Number

5

Dosage Form

-

Strength

20MG

Approval Date

2023-03-06

Regulatory Status

RX

2023
06 Mar
RX Application: 213885

Drug Name

LENALIDOMIDE

Product Number

6

Dosage Form

-

Strength

25MG

Approval Date

2023-03-06

213885 / 6

Active Ingredient

LENALIDOMIDE

Application Number

213885

Product Number

6

Dosage Form

-

Strength

25MG

Approval Date

2023-03-06

Regulatory Status

RX

2019
11 Jan
RX Application: 211717

Drug Name

LETROZOLE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2019-01-11

211717 / 1

Active Ingredient

LETROZOLE

Application Number

211717

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2019-01-11

Regulatory Status

RX

2022
06 Jun
RX Application: 212963

Drug Name

LEUPROLIDE ACETATE

Product Number

1

Dosage Form

-

Strength

14MG/2.8ML (1MG/0.2ML)

Approval Date

2022-06-06

212963 / 1

Active Ingredient

LEUPROLIDE ACETATE

Application Number

212963

Product Number

1

Dosage Form

-

Strength

14MG/2.8ML (1MG/0.2ML)

Approval Date

2022-06-06

Regulatory Status

RX

2016
01 Feb
RX Application: 204312

Drug Name

LEVETIRACETAM

Product Number

1

Dosage Form

-

Strength

500MG/5ML (100MG/ML)

Approval Date

2016-02-01

204312 / 1

Active Ingredient

LEVETIRACETAM

Application Number

204312

Product Number

1

Dosage Form

-

Strength

500MG/5ML (100MG/ML)

Approval Date

2016-02-01

Regulatory Status

RX

2017
04 Jan
RX Application: 207160

Drug Name

LEVETIRACETAM IN SODIUM CHLORIDE

Product Number

1

Dosage Form

-

Strength

500MG/100ML (5MG/ML)

Approval Date

2017-01-04

207160 / 1

Active Ingredient

LEVETIRACETAM

Application Number

207160

Product Number

1

Dosage Form

-

Strength

500MG/100ML (5MG/ML)

Approval Date

2017-01-04

Regulatory Status

RX

2017
04 Jan
RX Application: 207160

Drug Name

LEVETIRACETAM IN SODIUM CHLORIDE

Product Number

2

Dosage Form

-

Strength

1GM/100ML (10MG/ML)

Approval Date

2017-01-04

207160 / 2

Active Ingredient

LEVETIRACETAM

Application Number

207160

Product Number

2

Dosage Form

-

Strength

1GM/100ML (10MG/ML)

Approval Date

2017-01-04

Regulatory Status

RX

2017
04 Jan
RX Application: 207160

Drug Name

LEVETIRACETAM IN SODIUM CHLORIDE

Product Number

3

Dosage Form

-

Strength

1.5GM/100ML (15MG/ML)

Approval Date

2017-01-04

207160 / 3

Active Ingredient

LEVETIRACETAM

Application Number

207160

Product Number

3

Dosage Form

-

Strength

1.5GM/100ML (15MG/ML)

Approval Date

2017-01-04

Regulatory Status

RX

2013
24 Jan
Discontinued Application: 202328

Drug Name

LEVOFLOXACIN

Product Number

1

Dosage Form

-

Strength

EQ 500MG/20ML (EQ 25MG/ML)

Approval Date

2013-01-24

202328 / 1

Active Ingredient

LEVOFLOXACIN

Application Number

202328

Product Number

1

Dosage Form

-

Strength

EQ 500MG/20ML (EQ 25MG/ML)

Approval Date

2013-01-24

Regulatory Status

Discontinued

2013
24 Jan
Discontinued Application: 202328

Drug Name

LEVOFLOXACIN

Product Number

2

Dosage Form

-

Strength

EQ 750MG/30ML (EQ 25MG/ML)

Approval Date

2013-01-24

202328 / 2

Active Ingredient

LEVOFLOXACIN

Application Number

202328

Product Number

2

Dosage Form

-

Strength

EQ 750MG/30ML (EQ 25MG/ML)

Approval Date

2013-01-24

Regulatory Status

Discontinued

2016
10 Feb
Discontinued Application: 206919

Drug Name

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

1

Dosage Form

-

Strength

EQ 250MG/50ML (EQ 5MG/ML)

Approval Date

2016-02-10

206919 / 1

Active Ingredient

LEVOFLOXACIN

Application Number

206919

Product Number

1

Dosage Form

-

Strength

EQ 250MG/50ML (EQ 5MG/ML)

Approval Date

2016-02-10

Regulatory Status

Discontinued

2016
10 Feb
Discontinued Application: 206919

Drug Name

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

2

Dosage Form

-

Strength

EQ 500MG/100ML (EQ 5MG/ML)

Approval Date

2016-02-10

206919 / 2

Active Ingredient

LEVOFLOXACIN

Application Number

206919

Product Number

2

Dosage Form

-

Strength

EQ 500MG/100ML (EQ 5MG/ML)

Approval Date

2016-02-10

Regulatory Status

Discontinued

2016
10 Feb
Discontinued Application: 206919

Drug Name

LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER

Product Number

3

Dosage Form

-

Strength

EQ 750MG/150ML (EQ 5MG/ML)

Approval Date

2016-02-10

206919 / 3

Active Ingredient

LEVOFLOXACIN

Application Number

206919

Product Number

3

Dosage Form

-

Strength

EQ 750MG/150ML (EQ 5MG/ML)

Approval Date

2016-02-10

Regulatory Status

Discontinued

2017
30 Oct
RX Application: 207182

Drug Name

LIDOCAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2017-10-30

207182 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

207182

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2017-10-30

Regulatory Status

RX

2017
30 Oct
RX Application: 207182

Drug Name

LIDOCAINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

2017-10-30

207182 / 2

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

207182

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

2017-10-30

Regulatory Status

RX

2013
14 Mar
Discontinued Application: 203040

Drug Name

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2013-03-14

203040 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

203040

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2013-03-14

Regulatory Status

Discontinued

2013
14 Mar
Discontinued Application: 203040

Drug Name

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

2013-03-14

203040 / 2

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

203040

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

2013-03-14

Regulatory Status

Discontinued

2013
14 Mar
RX Application: 203082

Drug Name

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2013-03-14

203082 / 1

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

203082

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2013-03-14

Regulatory Status

RX

2013
14 Mar
RX Application: 203082

Drug Name

LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

2013-03-14

203082 / 2

Active Ingredient

LIDOCAINE HYDROCHLORIDE

Application Number

203082

Product Number

2

Dosage Form

-

Strength

2%

Approval Date

2013-03-14

Regulatory Status

RX

2023
07 Nov
Discontinued Application: 215063

Drug Name

LIFITEGRAST

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2023-11-07

215063 / 1

Active Ingredient

LIFITEGRAST

Application Number

215063

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2023-11-07

Regulatory Status

Discontinued

2016
04 Aug
RX Application: 206917

Drug Name

LINEZOLID

Product Number

1

Dosage Form

-

Strength

600MG/300ML (2MG/ML)

Approval Date

2016-08-04

206917 / 1

Active Ingredient

LINEZOLID

Application Number

206917

Product Number

1

Dosage Form

-

Strength

600MG/300ML (2MG/ML)

Approval Date

2016-08-04

Regulatory Status

RX

2022
22 Aug
RX Application: 212824

Drug Name

MEDROXYPROGESTERONE ACETATE

Product Number

1

Dosage Form

-

Strength

150MG/ML

Approval Date

2022-08-22

212824 / 1

Active Ingredient

MEDROXYPROGESTERONE ACETATE

Application Number

212824

Product Number

1

Dosage Form

-

Strength

150MG/ML

Approval Date

2022-08-22

Regulatory Status

RX

2022
31 Aug
RX Application: 212844

Drug Name

MEDROXYPROGESTERONE ACETATE

Product Number

1

Dosage Form

-

Strength

150MG/ML

Approval Date

2022-08-31

212844 / 1

Active Ingredient

MEDROXYPROGESTERONE ACETATE

Application Number

212844

Product Number

1

Dosage Form

-

Strength

150MG/ML

Approval Date

2022-08-31

Regulatory Status

RX

2017
27 Mar
RX Application: 205835

Drug Name

MEROPENEM

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2017-03-27

205835 / 1

Active Ingredient

MEROPENEM

Application Number

205835

Product Number

1

Dosage Form

-

Strength

500MG/VIAL

Approval Date

2017-03-27

Regulatory Status

RX

2017
27 Mar
RX Application: 205835

Drug Name

MEROPENEM

Product Number

2

Dosage Form

-

Strength

1GM/VIAL

Approval Date

2017-03-27

205835 / 2

Active Ingredient

MEROPENEM

Application Number

205835

Product Number

2

Dosage Form

-

Strength

1GM/VIAL

Approval Date

2017-03-27

Regulatory Status

RX

2026
27 Jan
RX Application: 220518

Drug Name

MESNA

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2026-01-27

220518 / 1

Active Ingredient

MESNA

Application Number

220518

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2026-01-27

Regulatory Status

RX

2016
27 May
RX Application: 206128

Drug Name

METHOCARBAMOL

Product Number

1

Dosage Form

-

Strength

1GM/10ML (100MG/ML)

Approval Date

2016-05-27

206128 / 1

Active Ingredient

METHOCARBAMOL

Application Number

206128

Product Number

1

Dosage Form

-

Strength

1GM/10ML (100MG/ML)

Approval Date

2016-05-27

Regulatory Status

RX

2020
30 Jan
RX Application: 210454

Drug Name

METHOTREXATE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2020-01-30

210454 / 1

Active Ingredient

METHOTREXATE SODIUM

Application Number

210454

Product Number

1

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2020-01-30

Regulatory Status

RX

2023
13 Apr
RX Application: 211930

Drug Name

METHYLPREDNISOLONE ACETATE

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2023-04-13

211930 / 1

Active Ingredient

METHYLPREDNISOLONE ACETATE

Application Number

211930

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2023-04-13

Regulatory Status

RX

2023
13 Apr
RX Application: 211930

Drug Name

METHYLPREDNISOLONE ACETATE

Product Number

2

Dosage Form

-

Strength

80MG/ML

Approval Date

2023-04-13

211930 / 2

Active Ingredient

METHYLPREDNISOLONE ACETATE

Application Number

211930

Product Number

2

Dosage Form

-

Strength

80MG/ML

Approval Date

2023-04-13

Regulatory Status

RX

2015
15 Dec
Discontinued Application: 207667

Drug Name

METHYLPREDNISOLONE SODIUM SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

2015-12-15

207667 / 1

Active Ingredient

METHYLPREDNISOLONE SODIUM SUCCINATE

Application Number

207667

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

2015-12-15

Regulatory Status

Discontinued

2015
15 Dec
Discontinued Application: 207667

Drug Name

METHYLPREDNISOLONE SODIUM SUCCINATE

Product Number

2

Dosage Form

-

Strength

EQ 125MG BASE/VIAL

Approval Date

2015-12-15

207667 / 2

Active Ingredient

METHYLPREDNISOLONE SODIUM SUCCINATE

Application Number

207667

Product Number

2

Dosage Form

-

Strength

EQ 125MG BASE/VIAL

Approval Date

2015-12-15

Regulatory Status

Discontinued

2015
15 Dec
Discontinued Application: 207667

Drug Name

METHYLPREDNISOLONE SODIUM SUCCINATE

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2015-12-15

207667 / 3

Active Ingredient

METHYLPREDNISOLONE SODIUM SUCCINATE

Application Number

207667

Product Number

3

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2015-12-15

Regulatory Status

Discontinued

2015
15 Dec
Discontinued Application: 207667

Drug Name

METHYLPREDNISOLONE SODIUM SUCCINATE

Product Number

4

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2015-12-15

207667 / 4

Active Ingredient

METHYLPREDNISOLONE SODIUM SUCCINATE

Application Number

207667

Product Number

4

Dosage Form

-

Strength

EQ 2GM BASE/VIAL

Approval Date

2015-12-15

Regulatory Status

Discontinued

2020
03 Sep
RX Application: 209666

Drug Name

MILRINONE LACTATE IN DEXTROSE 5%

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)

Approval Date

2020-09-03

209666 / 1

Active Ingredient

MILRINONE LACTATE

Application Number

209666

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML)

Approval Date

2020-09-03

Regulatory Status

RX

2020
03 Sep
RX Application: 209666

Drug Name

MILRINONE LACTATE IN DEXTROSE 5%

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)

Approval Date

2020-09-03

209666 / 2

Active Ingredient

MILRINONE LACTATE

Application Number

209666

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML)

Approval Date

2020-09-03

Regulatory Status

RX

2023
30 Oct
Discontinued Application: 216732

Drug Name

MITOMYCIN

Product Number

1

Dosage Form

-

Strength

5MG/VIAL

Approval Date

2023-10-30

216732 / 1

Active Ingredient

MITOMYCIN

Application Number

216732

Product Number

1

Dosage Form

-

Strength

5MG/VIAL

Approval Date

2023-10-30

Regulatory Status

Discontinued

2023
30 Oct
Discontinued Application: 216732

Drug Name

MITOMYCIN

Product Number

2

Dosage Form

-

Strength

20MG/VIAL

Approval Date

2023-10-30

216732 / 2

Active Ingredient

MITOMYCIN

Application Number

216732

Product Number

2

Dosage Form

-

Strength

20MG/VIAL

Approval Date

2023-10-30

Regulatory Status

Discontinued

2023
30 Oct
Discontinued Application: 216732

Drug Name

MITOMYCIN

Product Number

3

Dosage Form

-

Strength

40MG/VIAL

Approval Date

2023-10-30

216732 / 3

Active Ingredient

MITOMYCIN

Application Number

216732

Product Number

3

Dosage Form

-

Strength

40MG/VIAL

Approval Date

2023-10-30

Regulatory Status

Discontinued

2017
04 Oct
RX Application: 206242

Drug Name

MOXIFLOXACIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2017-10-04

206242 / 1

Active Ingredient

MOXIFLOXACIN HYDROCHLORIDE

Application Number

206242

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2017-10-04

Regulatory Status

RX

2019
15 Oct
Discontinued Application: 212455

Drug Name

NALOXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

2019-10-15

212455 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

212455

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

2019-10-15

Regulatory Status

Discontinued

2019
04 Nov
RX Application: 212456

Drug Name

NALOXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

2019-11-04

212456 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

212456

Product Number

1

Dosage Form

-

Strength

0.4MG/ML

Approval Date

2019-11-04

Regulatory Status

RX

2021
14 Jan
RX Application: 213279

Drug Name

NALOXONE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2021-01-14

213279 / 1

Active Ingredient

NALOXONE HYDROCHLORIDE

Application Number

213279

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2021-01-14

Regulatory Status

RX

2023
02 Nov
Discontinued Application: 213244

Drug Name

NEOSTIGMINE METHYLSULFATE

Product Number

1

Dosage Form

-

Strength

5MG/10ML (0.5MG/ML)

Approval Date

2023-11-02

213244 / 1

Active Ingredient

NEOSTIGMINE METHYLSULFATE

Application Number

213244

Product Number

1

Dosage Form

-

Strength

5MG/10ML (0.5MG/ML)

Approval Date

2023-11-02

Regulatory Status

Discontinued

2023
02 Nov
Discontinued Application: 213244

Drug Name

NEOSTIGMINE METHYLSULFATE

Product Number

2

Dosage Form

-

Strength

10MG/10ML (1MG/ML)

Approval Date

2023-11-02

213244 / 2

Active Ingredient

NEOSTIGMINE METHYLSULFATE

Application Number

213244

Product Number

2

Dosage Form

-

Strength

10MG/10ML (1MG/ML)

Approval Date

2023-11-02

Regulatory Status

Discontinued

-
Unclassified Application: 213244

Drug Name

NEOSTIGMINE METHYLSULFATE

Product Number

3

Dosage Form

-

Strength

5MG/10ML(0.5MG/ML)

Approval Date

-

213244 / 3

Active Ingredient

NEOSTIGMINE METHYLSULFATE

Application Number

213244

Product Number

3

Dosage Form

-

Strength

5MG/10ML(0.5MG/ML)

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 213244

Drug Name

NEOSTIGMINE METHYLSULFATE

Product Number

4

Dosage Form

-

Strength

10MG/10ML(1MG/ML)

Approval Date

-

213244 / 4

Active Ingredient

NEOSTIGMINE METHYLSULFATE

Application Number

213244

Product Number

4

Dosage Form

-

Strength

10MG/10ML(1MG/ML)

Approval Date

-

Regulatory Status

Unclassified

2021
08 Apr
RX Application: 211121

Drug Name

NICARDIPINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

25MG/10ML (2.5MG/ML)

Approval Date

2021-04-08

211121 / 1

Active Ingredient

NICARDIPINE HYDROCHLORIDE

Application Number

211121

Product Number

1

Dosage Form

-

Strength

25MG/10ML (2.5MG/ML)

Approval Date

2021-04-08

Regulatory Status

RX

2020
22 Oct
RX Application: 210968

Drug Name

OLANZAPINE

Product Number

1

Dosage Form

-

Strength

10MG/VIAL

Approval Date

2020-10-22

210968 / 1

Active Ingredient

OLANZAPINE

Application Number

210968

Product Number

1

Dosage Form

-

Strength

10MG/VIAL

Approval Date

2020-10-22

Regulatory Status

RX

2015
18 Dec
OTC Application: 204812

Drug Name

OLOPATADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

2015-12-18

204812 / 1

Active Ingredient

OLOPATADINE HYDROCHLORIDE

Application Number

204812

Product Number

1

Dosage Form

-

Strength

EQ 0.1% BASE

Approval Date

2015-12-18

Regulatory Status

OTC

2019
04 Apr
OTC Application: 209995

Drug Name

OLOPATADINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.2% BASE

Approval Date

2019-04-04

209995 / 1

Active Ingredient

OLOPATADINE HYDROCHLORIDE

Application Number

209995

Product Number

1

Dosage Form

-

Strength

EQ 0.2% BASE

Approval Date

2019-04-04

Regulatory Status

OTC

2012
21 Dec
Discontinued Application: 202599

Drug Name

ONDANSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2012-12-21

202599 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

202599

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2012-12-21

Regulatory Status

Discontinued

2012
21 Dec
Discontinued Application: 202600

Drug Name

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2012-12-21

202600 / 1

Active Ingredient

ONDANSETRON HYDROCHLORIDE

Application Number

202600

Product Number

1

Dosage Form

-

Strength

EQ 2MG BASE/ML

Approval Date

2012-12-21

Regulatory Status

Discontinued

2017
06 Sep
Discontinued Application: 205529

Drug Name

OXALIPLATIN

Product Number

1

Dosage Form

-

Strength

50MG/10ML (5MG/ML)

Approval Date

2017-09-06

205529 / 1

Active Ingredient

OXALIPLATIN

Application Number

205529

Product Number

1

Dosage Form

-

Strength

50MG/10ML (5MG/ML)

Approval Date

2017-09-06

Regulatory Status

Discontinued

2017
06 Sep
Discontinued Application: 205529

Drug Name

OXALIPLATIN

Product Number

2

Dosage Form

-

Strength

100MG/20ML (5MG/ML)

Approval Date

2017-09-06

205529 / 2

Active Ingredient

OXALIPLATIN

Application Number

205529

Product Number

2

Dosage Form

-

Strength

100MG/20ML (5MG/ML)

Approval Date

2017-09-06

Regulatory Status

Discontinued

2018
06 Nov
RX Application: 204702

Drug Name

PALONOSETRON HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)

Approval Date

2018-11-06

204702 / 1

Active Ingredient

PALONOSETRON HYDROCHLORIDE

Application Number

204702

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)

Approval Date

2018-11-06

Regulatory Status

RX

2016
30 Mar
RX Application: 205675

Drug Name

PANTOPRAZOLE SODIUM

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

2016-03-30

205675 / 1

Active Ingredient

PANTOPRAZOLE SODIUM

Application Number

205675

Product Number

1

Dosage Form

-

Strength

EQ 40MG BASE/VIAL

Approval Date

2016-03-30

Regulatory Status

RX

2018
09 Oct
Discontinued Application: 205982

Drug Name

PARICALCITOL

Product Number

1

Dosage Form

-

Strength

0.002MG/ML (0.002MG/ML)

Approval Date

2018-10-09

205982 / 1

Active Ingredient

PARICALCITOL

Application Number

205982

Product Number

1

Dosage Form

-

Strength

0.002MG/ML (0.002MG/ML)

Approval Date

2018-10-09

Regulatory Status

Discontinued

2018
09 Oct
Discontinued Application: 205982

Drug Name

PARICALCITOL

Product Number

2

Dosage Form

-

Strength

0.005MG/ML (0.005MG/ML)

Approval Date

2018-10-09

205982 / 2

Active Ingredient

PARICALCITOL

Application Number

205982

Product Number

2

Dosage Form

-

Strength

0.005MG/ML (0.005MG/ML)

Approval Date

2018-10-09

Regulatory Status

Discontinued

2018
09 Oct
Discontinued Application: 205982

Drug Name

PARICALCITOL

Product Number

3

Dosage Form

-

Strength

0.01MG/2ML (0.005MG/ML)

Approval Date

2018-10-09

205982 / 3

Active Ingredient

PARICALCITOL

Application Number

205982

Product Number

3

Dosage Form

-

Strength

0.01MG/2ML (0.005MG/ML)

Approval Date

2018-10-09

Regulatory Status

Discontinued

2024
04 Dec
RX Application: 219034

Drug Name

PAZOPANIB HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2024-12-04

219034 / 1

Active Ingredient

PAZOPANIB HYDROCHLORIDE

Application Number

219034

Product Number

1

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2024-12-04

Regulatory Status

RX

2022
25 May
RX Application: 214632

Drug Name

PEMETREXED DISODIUM

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2022-05-25

214632 / 1

Active Ingredient

PEMETREXED DISODIUM

Application Number

214632

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE/VIAL

Approval Date

2022-05-25

Regulatory Status

RX

2022
25 May
RX Application: 214632

Drug Name

PEMETREXED DISODIUM

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2022-05-25

214632 / 2

Active Ingredient

PEMETREXED DISODIUM

Application Number

214632

Product Number

2

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2022-05-25

Regulatory Status

RX

2022
25 May
RX Application: 214632

Drug Name

PEMETREXED DISODIUM

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2022-05-25

214632 / 3

Active Ingredient

PEMETREXED DISODIUM

Application Number

214632

Product Number

3

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2022-05-25

Regulatory Status

RX

2021
07 Jan
RX Application: 210696

Drug Name

PHENYLEPHRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

10MG/ML (10MG/ML)

Approval Date

2021-01-07

210696 / 1

Active Ingredient

PHENYLEPHRINE HYDROCHLORIDE

Application Number

210696

Product Number

1

Dosage Form

-

Strength

10MG/ML (10MG/ML)

Approval Date

2021-01-07

Regulatory Status

RX

2020
13 Nov
RX Application: 210697

Drug Name

PHENYLEPHRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2020-11-13

210697 / 1

Active Ingredient

PHENYLEPHRINE HYDROCHLORIDE

Application Number

210697

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2020-11-13

Regulatory Status

RX

2020
13 Nov
RX Application: 210697

Drug Name

PHENYLEPHRINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2020-11-13

210697 / 2

Active Ingredient

PHENYLEPHRINE HYDROCHLORIDE

Application Number

210697

Product Number

2

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2020-11-13

Regulatory Status

RX

2023
12 Oct
Discontinued Application: 217409

Drug Name

PIPERACILLIN AND TAZOBACTAM

Product Number

1

Dosage Form

-

Strength

EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL

Approval Date

2023-10-12

217409 / 1

Active Ingredient

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Application Number

217409

Product Number

1

Dosage Form

-

Strength

EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL

Approval Date

2023-10-12

Regulatory Status

Discontinued

2023
12 Oct
Discontinued Application: 217409

Drug Name

PIPERACILLIN AND TAZOBACTAM

Product Number

2

Dosage Form

-

Strength

EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL

Approval Date

2023-10-12

217409 / 2

Active Ingredient

PIPERACILLIN SODIUM; TAZOBACTAM SODIUM

Application Number

217409

Product Number

2

Dosage Form

-

Strength

EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL

Approval Date

2023-10-12

Regulatory Status

Discontinued

-
Unclassified Application: 217409

Drug Name

PIPERACILLIN AND TAZOBACTAM

Product Number

3

Dosage Form

-

Strength

0.375G

Approval Date

-

217409 / 3

Active Ingredient

PIPERACILLIN,TAZOBACTAM

Application Number

217409

Product Number

3

Dosage Form

-

Strength

0.375G

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 217409

Drug Name

PIPERACILLIN AND TAZOBACTAM

Product Number

4

Dosage Form

-

Strength

3.0G

Approval Date

-

217409 / 4

Active Ingredient

PIPERACILLIN,TAZOBACTAM

Application Number

217409

Product Number

4

Dosage Form

-

Strength

3.0G

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 217409

Drug Name

PIPERACILLIN AND TAZOBACTAM

Product Number

5

Dosage Form

-

Strength

0.5G/1VIAL

Approval Date

-

217409 / 5

Active Ingredient

PIPERACILLIN,TAZOBACTAM

Application Number

217409

Product Number

5

Dosage Form

-

Strength

0.5G/1VIAL

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 217409

Drug Name

PIPERACILLIN AND TAZOBACTAM

Product Number

6

Dosage Form

-

Strength

4.0G

Approval Date

-

217409 / 6

Active Ingredient

PIPERACILLIN,TAZOBACTAM

Application Number

217409

Product Number

6

Dosage Form

-

Strength

4.0G

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 217409

Drug Name

PIPERACILLIN AND TAZOBACTAM

Product Number

7

Dosage Form

-

Strength

4.5G

Approval Date

-

217409 / 7

Active Ingredient

PIPERACILLIN,TAZOBACTAM

Application Number

217409

Product Number

7

Dosage Form

-

Strength

4.5G

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 217409

Drug Name

PIPERACILLIN AND TAZOBACTAM

Product Number

8

Dosage Form

-

Strength

36G

Approval Date

-

217409 / 8

Active Ingredient

PIPERACILLIN,TAZOBACTAM

Application Number

217409

Product Number

8

Dosage Form

-

Strength

36G

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 217409

Drug Name

PIPERACILLIN AND TAZOBACTAM

Product Number

9

Dosage Form

-

Strength

EQ 12GM BASE/VIAL;EQ 1.5GMBASE/VIAL

Approval Date

-

217409 / 9

Active Ingredient

PIPERACILLIN,TAZOBACTAM

Application Number

217409

Product Number

9

Dosage Form

-

Strength

EQ 12GM BASE/VIAL;EQ 1.5GMBASE/VIAL

Approval Date

-

Regulatory Status

Unclassified

-
Unclassified Application: 217409

Drug Name

PIPERACILLIN AND TAZOBACTAM

Product Number

10

Dosage Form

-

Strength

EQ 36GM BASE/VIAL;EQ 4.5GMBASE/VIAL

Approval Date

-

217409 / 10

Active Ingredient

PIPERACILLIN,TAZOBACTAM

Application Number

217409

Product Number

10

Dosage Form

-

Strength

EQ 36GM BASE/VIAL;EQ 4.5GMBASE/VIAL

Approval Date

-

Regulatory Status

Unclassified

2023
24 Jul
RX Application: 213672

Drug Name

PLERIXAFOR

Product Number

1

Dosage Form

-

Strength

24MG/1.2ML (20MG/ML)

Approval Date

2023-07-24

213672 / 1

Active Ingredient

PLERIXAFOR

Application Number

213672

Product Number

1

Dosage Form

-

Strength

24MG/1.2ML (20MG/ML)

Approval Date

2023-07-24

Regulatory Status

RX

2016
04 Apr
RX Application: 206589

Drug Name

POLYMYXIN B SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 500,000 UNITS BASE/VIAL

Approval Date

2016-04-04

206589 / 1

Active Ingredient

POLYMYXIN B SULFATE

Application Number

206589

Product Number

1

Dosage Form

-

Strength

EQ 500,000 UNITS BASE/VIAL

Approval Date

2016-04-04

Regulatory Status

RX

2020
30 Oct
RX Application: 210249

Drug Name

POMALIDOMIDE

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2020-10-30

210249 / 1

Active Ingredient

POMALIDOMIDE

Application Number

210249

Product Number

1

Dosage Form

-

Strength

1MG

Approval Date

2020-10-30

Regulatory Status

RX

2020
30 Oct
RX Application: 210249

Drug Name

POMALIDOMIDE

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2020-10-30

210249 / 2

Active Ingredient

POMALIDOMIDE

Application Number

210249

Product Number

2

Dosage Form

-

Strength

2MG

Approval Date

2020-10-30

Regulatory Status

RX

2020
30 Oct
RX Application: 210249

Drug Name

POMALIDOMIDE

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2020-10-30

210249 / 3

Active Ingredient

POMALIDOMIDE

Application Number

210249

Product Number

3

Dosage Form

-

Strength

3MG

Approval Date

2020-10-30

Regulatory Status

RX

2020
30 Oct
RX Application: 210249

Drug Name

POMALIDOMIDE

Product Number

4

Dosage Form

-

Strength

4MG

Approval Date

2020-10-30

210249 / 4

Active Ingredient

POMALIDOMIDE

Application Number

210249

Product Number

4

Dosage Form

-

Strength

4MG

Approval Date

2020-10-30

Regulatory Status

RX

2023
26 Dec
RX Application: 214842

Drug Name

POSACONAZOLE

Product Number

1

Dosage Form

-

Strength

300MG/16.7ML (18MG/ML)

Approval Date

2023-12-26

214842 / 1

Active Ingredient

POSACONAZOLE

Application Number

214842

Product Number

1

Dosage Form

-

Strength

300MG/16.7ML (18MG/ML)

Approval Date

2023-12-26

Regulatory Status

RX

2022
14 Jul
RX Application: 213873

Drug Name

PROCHLORPERAZINE EDISYLATE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2022-07-14

213873 / 1

Active Ingredient

PROCHLORPERAZINE EDISYLATE

Application Number

213873

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/ML

Approval Date

2022-07-14

Regulatory Status

RX

2018
06 Dec
RX Application: 210965

Drug Name

PROGESTERONE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2018-12-06

210965 / 1

Active Ingredient

PROGESTERONE

Application Number

210965

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2018-12-06

Regulatory Status

RX

2018
26 Oct
RX Application: 211285

Drug Name

PROGESTERONE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2018-10-26

211285 / 1

Active Ingredient

PROGESTERONE

Application Number

211285

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2018-10-26

Regulatory Status

RX

2018
26 Oct
RX Application: 211285

Drug Name

PROGESTERONE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2018-10-26

211285 / 2

Active Ingredient

PROGESTERONE

Application Number

211285

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2018-10-26

Regulatory Status

RX

2022
26 Oct
RX Application: 216437

Drug Name

REGADENOSON

Product Number

1

Dosage Form

-

Strength

0.4MG/5ML (0.08MG/ML)

Approval Date

2022-10-26

216437 / 1

Active Ingredient

REGADENOSON

Application Number

216437

Product Number

1

Dosage Form

-

Strength

0.4MG/5ML (0.08MG/ML)

Approval Date

2022-10-26

Regulatory Status

RX

2017
12 Apr
RX Application: 206206

Drug Name

ROCURONIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2017-04-12

206206 / 1

Active Ingredient

ROCURONIUM BROMIDE

Application Number

206206

Product Number

1

Dosage Form

-

Strength

50MG/5ML (10MG/ML)

Approval Date

2017-04-12

Regulatory Status

RX

2017
12 Apr
RX Application: 206206

Drug Name

ROCURONIUM BROMIDE

Product Number

2

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2017-04-12

206206 / 2

Active Ingredient

ROCURONIUM BROMIDE

Application Number

206206

Product Number

2

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2017-04-12

Regulatory Status

RX

2016
13 Jul
RX Application: 205612

Drug Name

ROPIVACAINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

40MG/20ML (2MG/ML)

Approval Date

2016-07-13

205612 / 1

Active Ingredient

ROPIVACAINE HYDROCHLORIDE

Application Number

205612

Product Number

1

Dosage Form

-

Strength

40MG/20ML (2MG/ML)

Approval Date

2016-07-13

Regulatory Status

RX

2016
13 Jul
RX Application: 205612

Drug Name

ROPIVACAINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2016-07-13

205612 / 2

Active Ingredient

ROPIVACAINE HYDROCHLORIDE

Application Number

205612

Product Number

2

Dosage Form

-

Strength

200MG/100ML (2MG/ML)

Approval Date

2016-07-13

Regulatory Status

RX

2016
13 Jul
RX Application: 205612

Drug Name

ROPIVACAINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

100MG/20ML (5MG/ML)

Approval Date

2016-07-13

205612 / 3

Active Ingredient

ROPIVACAINE HYDROCHLORIDE

Application Number

205612

Product Number

3

Dosage Form

-

Strength

100MG/20ML (5MG/ML)

Approval Date

2016-07-13

Regulatory Status

RX

2016
13 Jul
RX Application: 205612

Drug Name

ROPIVACAINE HYDROCHLORIDE

Product Number

4

Dosage Form

-

Strength

150MG/30ML (5MG/ML)

Approval Date

2016-07-13

205612 / 4

Active Ingredient

ROPIVACAINE HYDROCHLORIDE

Application Number

205612

Product Number

4

Dosage Form

-

Strength

150MG/30ML (5MG/ML)

Approval Date

2016-07-13

Regulatory Status

RX

2016
13 Jul
RX Application: 205612

Drug Name

ROPIVACAINE HYDROCHLORIDE

Product Number

5

Dosage Form

-

Strength

150MG/20ML (7.5MG/ML)

Approval Date

2016-07-13

205612 / 5

Active Ingredient

ROPIVACAINE HYDROCHLORIDE

Application Number

205612

Product Number

5

Dosage Form

-

Strength

150MG/20ML (7.5MG/ML)

Approval Date

2016-07-13

Regulatory Status

RX

2016
13 Jul
RX Application: 205612

Drug Name

ROPIVACAINE HYDROCHLORIDE

Product Number

6

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2016-07-13

205612 / 6

Active Ingredient

ROPIVACAINE HYDROCHLORIDE

Application Number

205612

Product Number

6

Dosage Form

-

Strength

100MG/10ML (10MG/ML)

Approval Date

2016-07-13

Regulatory Status

RX

2016
13 Jul
RX Application: 205612

Drug Name

ROPIVACAINE HYDROCHLORIDE

Product Number

7

Dosage Form

-

Strength

200MG/20ML (10MG/ML)

Approval Date

2016-07-13

205612 / 7

Active Ingredient

ROPIVACAINE HYDROCHLORIDE

Application Number

205612

Product Number

7

Dosage Form

-

Strength

200MG/20ML (10MG/ML)

Approval Date

2016-07-13

Regulatory Status

RX

2015
01 Apr
RX Application: 203988

Drug Name

SILDENAFIL CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)

Approval Date

2015-04-01

203988 / 1

Active Ingredient

SILDENAFIL CITRATE

Application Number

203988

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)

Approval Date

2015-04-01

Regulatory Status

RX

2020
10 Dec
Discontinued Application: 211934

Drug Name

SODIUM NITROPRUSSIDE

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

2020-12-10

211934 / 1

Active Ingredient

SODIUM NITROPRUSSIDE

Application Number

211934

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

2020-12-10

Regulatory Status

Discontinued

2023
16 Oct
Discontinued Application: 217808

Drug Name

SUCCINYLCHOLINE CHLORIDE

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

2023-10-16

217808 / 1

Active Ingredient

SUCCINYLCHOLINE CHLORIDE

Application Number

217808

Product Number

1

Dosage Form

-

Strength

20MG/ML

Approval Date

2023-10-16

Regulatory Status

Discontinued

2013
23 Apr
RX Application: 202758

Drug Name

SUMATRIPTAN SUCCINATE

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

Approval Date

2013-04-23

202758 / 1

Active Ingredient

SUMATRIPTAN SUCCINATE

Application Number

202758

Product Number

1

Dosage Form

-

Strength

EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)

Approval Date

2013-04-23

Regulatory Status

RX

2024
14 Mar
RX Application: 218615

Drug Name

SUNITINIB MALATE

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG BASE

Approval Date

2024-03-14

218615 / 1

Active Ingredient

SUNITINIB MALATE

Application Number

218615

Product Number

1

Dosage Form

-

Strength

EQ 12.5MG BASE

Approval Date

2024-03-14

Regulatory Status

RX

2024
14 Mar
RX Application: 218615

Drug Name

SUNITINIB MALATE

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2024-03-14

218615 / 2

Active Ingredient

SUNITINIB MALATE

Application Number

218615

Product Number

2

Dosage Form

-

Strength

EQ 25MG BASE

Approval Date

2024-03-14

Regulatory Status

RX

2024
14 Mar
RX Application: 218615

Drug Name

SUNITINIB MALATE

Product Number

3

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2024-03-14

218615 / 3

Active Ingredient

SUNITINIB MALATE

Application Number

218615

Product Number

3

Dosage Form

-

Strength

EQ 37.5MG BASE

Approval Date

2024-03-14

Regulatory Status

RX

2024
14 Mar
RX Application: 218615

Drug Name

SUNITINIB MALATE

Product Number

4

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2024-03-14

218615 / 4

Active Ingredient

SUNITINIB MALATE

Application Number

218615

Product Number

4

Dosage Form

-

Strength

EQ 50MG BASE

Approval Date

2024-03-14

Regulatory Status

RX

2020
14 Aug
RX Application: 213358

Drug Name

TAMOXIFEN CITRATE

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2020-08-14

213358 / 1

Active Ingredient

TAMOXIFEN CITRATE

Application Number

213358

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2020-08-14

Regulatory Status

RX

2020
14 Aug
RX Application: 213358

Drug Name

TAMOXIFEN CITRATE

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2020-08-14

213358 / 2

Active Ingredient

TAMOXIFEN CITRATE

Application Number

213358

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2020-08-14

Regulatory Status

RX

2023
20 Oct
RX Application: 211817

Drug Name

TESTOSTERONE CYPIONATE

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2023-10-20

211817 / 1

Active Ingredient

TESTOSTERONE CYPIONATE

Application Number

211817

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2023-10-20

Regulatory Status

RX

2023
20 Oct
RX Application: 211817

Drug Name

TESTOSTERONE CYPIONATE

Product Number

2

Dosage Form

-

Strength

200MG/ML

Approval Date

2023-10-20

211817 / 2

Active Ingredient

TESTOSTERONE CYPIONATE

Application Number

211817

Product Number

2

Dosage Form

-

Strength

200MG/ML

Approval Date

2023-10-20

Regulatory Status

RX

-
Unclassified Application: 211817

Drug Name

TESTOSTERONE CYPIONATE

Product Number

3

Dosage Form

-

Strength

200MG/ML

Approval Date

-

211817 / 3

Active Ingredient

TESTOSTERONE CYPIONATE

Application Number

211817

Product Number

3

Dosage Form

-

Strength

200MG/ML

Approval Date

-

Regulatory Status

Unclassified

2024
28 Feb
RX Application: 212659

Drug Name

TESTOSTERONE ENANTHATE

Product Number

1

Dosage Form

-

Strength

200MG/ML

Approval Date

2024-02-28

212659 / 1

Active Ingredient

TESTOSTERONE ENANTHATE

Application Number

212659

Product Number

1

Dosage Form

-

Strength

200MG/ML

Approval Date

2024-02-28

Regulatory Status

RX

2022
20 Apr
RX Application: 208703

Drug Name

THIAMINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2022-04-20

208703 / 1

Active Ingredient

THIAMINE HYDROCHLORIDE

Application Number

208703

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2022-04-20

Regulatory Status

RX

2019
11 Jun
RX Application: 206335

Drug Name

TIGECYCLINE

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2019-06-11

206335 / 1

Active Ingredient

TIGECYCLINE

Application Number

206335

Product Number

1

Dosage Form

-

Strength

50MG/VIAL

Approval Date

2019-06-11

Regulatory Status

RX

2023
23 Mar
RX Application: 213540

Drug Name

TIMOLOL MALEATE

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2023-03-23

213540 / 1

Active Ingredient

TIMOLOL MALEATE

Application Number

213540

Product Number

1

Dosage Form

-

Strength

EQ 0.5% BASE

Approval Date

2023-03-23

Regulatory Status

RX

2023
01 May
RX Application: 216379

Drug Name

TIROFIBAN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)

Approval Date

2023-05-01

216379 / 1

Active Ingredient

TIROFIBAN HYDROCHLORIDE

Application Number

216379

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)

Approval Date

2023-05-01

Regulatory Status

RX

2023
01 May
RX Application: 216379

Drug Name

TIROFIBAN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)

Approval Date

2023-05-01

216379 / 2

Active Ingredient

TIROFIBAN HYDROCHLORIDE

Application Number

216379

Product Number

2

Dosage Form

-

Strength

EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)

Approval Date

2023-05-01

Regulatory Status

RX

2023
21 Jun
RX Application: 217519

Drug Name

TOBRAMYCIN SULFATE

Product Number

1

Dosage Form

-

Strength

EQ 1.2GM BASE/VIAL

Approval Date

2023-06-21

217519 / 1

Active Ingredient

TOBRAMYCIN SULFATE

Application Number

217519

Product Number

1

Dosage Form

-

Strength

EQ 1.2GM BASE/VIAL

Approval Date

2023-06-21

Regulatory Status

RX

2016
14 Jan
RX Application: 205035

Drug Name

TRANEXAMIC ACID

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2016-01-14

205035 / 1

Active Ingredient

TRANEXAMIC ACID

Application Number

205035

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2016-01-14

Regulatory Status

RX

2022
05 Jul
RX Application: 212400

Drug Name

TRIAMCINOLONE ACETONIDE

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2022-07-05

212400 / 1

Active Ingredient

TRIAMCINOLONE ACETONIDE

Application Number

212400

Product Number

1

Dosage Form

-

Strength

40MG/ML

Approval Date

2022-07-05

Regulatory Status

RX

2016
29 Mar
RX Application: 205779

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 5GM BASE/VIAL

Approval Date

2016-03-29

205779 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

205779

Product Number

1

Dosage Form

-

Strength

EQ 5GM BASE/VIAL

Approval Date

2016-03-29

Regulatory Status

RX

2016
29 Mar
RX Application: 205779

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2016-03-29

205779 / 2

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

205779

Product Number

2

Dosage Form

-

Strength

EQ 10GM BASE/VIAL

Approval Date

2016-03-29

Regulatory Status

RX

2016
31 Mar
RX Application: 205780

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2016-03-31

205780 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

205780

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2016-03-31

Regulatory Status

RX

2016
31 Mar
RX Application: 205780

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2016-03-31

205780 / 2

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

205780

Product Number

2

Dosage Form

-

Strength

EQ 1GM BASE/VIAL

Approval Date

2016-03-31

Regulatory Status

RX

2023
04 Aug
RX Application: 217401

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1.25GM BASE/VIAL

Approval Date

2023-08-04

217401 / 1

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

217401

Product Number

1

Dosage Form

-

Strength

EQ 1.25GM BASE/VIAL

Approval Date

2023-08-04

Regulatory Status

RX

2023
04 Aug
RX Application: 217401

Drug Name

VANCOMYCIN HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 1.5GM BASE/VIAL

Approval Date

2023-08-04

217401 / 2

Active Ingredient

VANCOMYCIN HYDROCHLORIDE

Application Number

217401

Product Number

2

Dosage Form

-

Strength

EQ 1.5GM BASE/VIAL

Approval Date

2023-08-04

Regulatory Status

RX

2022
15 Aug
RX Application: 214314

Drug Name

VASOPRESSIN

Product Number

1

Dosage Form

-

Strength

20UNITS/ML (20UNITS/ML)

Approval Date

2022-08-15

214314 / 1

Active Ingredient

VASOPRESSIN

Application Number

214314

Product Number

1

Dosage Form

-

Strength

20UNITS/ML (20UNITS/ML)

Approval Date

2022-08-15

Regulatory Status

RX

2018
20 Dec
RX Application: 206670

Drug Name

VECURONIUM BROMIDE

Product Number

1

Dosage Form

-

Strength

10MG/VIAL

Approval Date

2018-12-20

206670 / 1

Active Ingredient

VECURONIUM BROMIDE

Application Number

206670

Product Number

1

Dosage Form

-

Strength

10MG/VIAL

Approval Date

2018-12-20

Regulatory Status

RX

2018
20 Dec
RX Application: 206670

Drug Name

VECURONIUM BROMIDE

Product Number

2

Dosage Form

-

Strength

20MG/VIAL

Approval Date

2018-12-20

206670 / 2

Active Ingredient

VECURONIUM BROMIDE

Application Number

206670

Product Number

2

Dosage Form

-

Strength

20MG/VIAL

Approval Date

2018-12-20

Regulatory Status

RX

2020
06 Jul
RX Application: 212965

Drug Name

VERAPAMIL HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

2020-07-06

212965 / 1

Active Ingredient

VERAPAMIL HYDROCHLORIDE

Application Number

212965

Product Number

1

Dosage Form

-

Strength

2.5MG/ML

Approval Date

2020-07-06

Regulatory Status

RX

2023
02 Feb
Discontinued Application: 212162

Drug Name

VORICONAZOLE

Product Number

1

Dosage Form

-

Strength

200MG/VIAL

Approval Date

2023-02-02

212162 / 1

Active Ingredient

VORICONAZOLE

Application Number

212162

Product Number

1

Dosage Form

-

Strength

200MG/VIAL

Approval Date

2023-02-02

Regulatory Status

Discontinued

2016
26 Sep
Discontinued Application: 207751

Drug Name

ZOLEDRONIC ACID

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/5ML

Approval Date

2016-09-26

207751 / 1

Active Ingredient

ZOLEDRONIC ACID

Application Number

207751

Product Number

1

Dosage Form

-

Strength

EQ 4MG BASE/5ML

Approval Date

2016-09-26

Regulatory Status

Discontinued

2017
08 Dec
Discontinued Application: 209125

Drug Name

ZOLEDRONIC ACID

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/100ML

Approval Date

2017-12-08

209125 / 1

Active Ingredient

ZOLEDRONIC ACID

Application Number

209125

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE/100ML

Approval Date

2017-12-08

Regulatory Status

Discontinued

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Drug Status Breakdown
256 total
  • RX
  • Discontinued
  • Unclassified
  • OTC
Official Source

FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

Explore important FDA approved drug information available in the records above.

Drug Name

ACETAMINOPHEN

Application Number

210969

Product Number

1

Active Ingredient

ACETAMINOPHEN

Dosage Form

-

Strength

1GM/100ML (10MG/ML)

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

Reliable Data

Organized FDA drug records

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