AbbVie Inc RX
FDA Approved Drugs

AbbVie Inc RX

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
  • Total Records 122
  • Latest Approval Date Dec 18, 2025
  • Data Source FDA
  • First Approval Date Jan 01, 1982
All
301
View
Unclassified
19
View
Discontinued
158
View
OTC
2
View
RX
122
View
Company Overview

Company

AbbVie Inc RX

Country

U.S.A

Website

Visit Website

Email

abbviecontractmfg@abbvie.com

Social Profiles

LinkedIn X / Twitter
Company Snapshot

AbbVie Inc RX

1 North Waukegan Road North Chicago, IL 60064

U.S.A

www.abbvie.com/ abbviecontractmfg@abbvie.com View on Map
FDA Approved Drug Records ( 122 records )
1992
09 Nov
RX Application: 19700

Drug Name

ACULAR

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1992-11-09

19700 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

19700

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

1992-11-09

Regulatory Status

RX

2003
30 May
RX Application: 21528

Drug Name

ACULAR LS

Product Number

1

Dosage Form

-

Strength

0.4%

Approval Date

2003-05-30

21528 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

21528

Product Number

1

Dosage Form

-

Strength

0.4%

Approval Date

2003-05-30

Regulatory Status

RX

2009
22 Jul
RX Application: 22427

Drug Name

ACUVAIL

Product Number

1

Dosage Form

-

Strength

0.45%

Approval Date

2009-07-22

22427 / 1

Active Ingredient

KETOROLAC TROMETHAMINE

Application Number

22427

Product Number

1

Dosage Form

-

Strength

0.45%

Approval Date

2009-07-22

Regulatory Status

RX

2001
16 Mar
RX Application: 21262

Drug Name

ALPHAGAN P

Product Number

1

Dosage Form

-

Strength

0.15%

Approval Date

2001-03-16

21262 / 1

Active Ingredient

BRIMONIDINE TARTRATE

Application Number

21262

Product Number

1

Dosage Form

-

Strength

0.15%

Approval Date

2001-03-16

Regulatory Status

RX

2005
19 Aug
RX Application: 21770

Drug Name

ALPHAGAN P

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2005-08-19

21770 / 1

Active Ingredient

BRIMONIDINE TARTRATE

Application Number

21770

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2005-08-19

Regulatory Status

RX

2015
25 Feb
RX Application: 206494

Drug Name

AVYCAZ

Product Number

1

Dosage Form

-

Strength

EQ 0.5GM BASE;2GM/VIAL

Approval Date

2015-02-25

206494 / 1

Active Ingredient

AVIBACTAM SODIUM; CEFTAZIDIME

Application Number

206494

Product Number

1

Dosage Form

-

Strength

EQ 0.5GM BASE;2GM/VIAL

Approval Date

2015-02-25

Regulatory Status

RX

2004
05 Nov
RX Application: 21252

Drug Name

CANASA

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2004-11-05

21252 / 2

Active Ingredient

MESALAMINE

Application Number

21252

Product Number

2

Dosage Form

-

Strength

1GM

Approval Date

2004-11-05

Regulatory Status

RX

1982
01 Jan
RX Application: 18333

Drug Name

CARAFATE

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

1982-01-01

18333 / 1

Active Ingredient

SUCRALFATE

Application Number

18333

Product Number

1

Dosage Form

-

Strength

1GM

Approval Date

1982-01-01

Regulatory Status

RX

2000
27 Apr
RX Application: 20822

Drug Name

CELEXA

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2000-04-27

20822 / 1

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

20822

Product Number

1

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2000-04-27

Regulatory Status

RX

1998
17 Jul
RX Application: 20822

Drug Name

CELEXA

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

1998-07-17

20822 / 2

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

20822

Product Number

2

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

1998-07-17

Regulatory Status

RX

1998
17 Jul
RX Application: 20822

Drug Name

CELEXA

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

1998-07-17

20822 / 3

Active Ingredient

CITALOPRAM HYDROBROMIDE

Application Number

20822

Product Number

3

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

1998-07-17

Regulatory Status

RX

2007
30 Oct
RX Application: 21398

Drug Name

COMBIGAN

Product Number

1

Dosage Form

-

Strength

0.2%;EQ 0.5% BASE

Approval Date

2007-10-30

21398 / 1

Active Ingredient

BRIMONIDINE TARTRATE; TIMOLOL MALEATE

Application Number

21398

Product Number

1

Dosage Form

-

Strength

0.2%;EQ 0.5% BASE

Approval Date

2007-10-30

Regulatory Status

RX

1997
31 Jul
RX Application: 20701

Drug Name

CRINONE

Product Number

2

Dosage Form

-

Strength

8%

Approval Date

1997-07-31

20701 / 2

Active Ingredient

PROGESTERONE

Application Number

20701

Product Number

2

Dosage Form

-

Strength

8%

Approval Date

1997-07-31

Regulatory Status

RX

2014
23 May
RX Application: 21883

Drug Name

DALVANCE

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2014-05-23

21883 / 1

Active Ingredient

DALBAVANCIN HYDROCHLORIDE

Application Number

21883

Product Number

1

Dosage Form

-

Strength

EQ 500MG BASE/VIAL

Approval Date

2014-05-23

Regulatory Status

RX

1983
10 Mar
RX Application: 18723

Drug Name

DEPAKOTE

Product Number

1

Dosage Form

-

Strength

EQ 250MG VALPROIC ACID

Approval Date

1983-03-10

18723 / 1

Active Ingredient

DIVALPROEX SODIUM

Application Number

18723

Product Number

1

Dosage Form

-

Strength

EQ 250MG VALPROIC ACID

Approval Date

1983-03-10

Regulatory Status

RX

1983
10 Mar
RX Application: 18723

Drug Name

DEPAKOTE

Product Number

2

Dosage Form

-

Strength

EQ 500MG VALPROIC ACID

Approval Date

1983-03-10

18723 / 2

Active Ingredient

DIVALPROEX SODIUM

Application Number

18723

Product Number

2

Dosage Form

-

Strength

EQ 500MG VALPROIC ACID

Approval Date

1983-03-10

Regulatory Status

RX

1984
26 Oct
RX Application: 18723

Drug Name

DEPAKOTE

Product Number

3

Dosage Form

-

Strength

EQ 125MG VALPROIC ACID

Approval Date

1984-10-26

18723 / 3

Active Ingredient

DIVALPROEX SODIUM

Application Number

18723

Product Number

3

Dosage Form

-

Strength

EQ 125MG VALPROIC ACID

Approval Date

1984-10-26

Regulatory Status

RX

1989
12 Sep
RX Application: 19680

Drug Name

DEPAKOTE

Product Number

1

Dosage Form

-

Strength

EQ 125MG VALPROIC ACID

Approval Date

1989-09-12

19680 / 1

Active Ingredient

DIVALPROEX SODIUM

Application Number

19680

Product Number

1

Dosage Form

-

Strength

EQ 125MG VALPROIC ACID

Approval Date

1989-09-12

Regulatory Status

RX

2000
04 Aug
RX Application: 21168

Drug Name

DEPAKOTE ER

Product Number

1

Dosage Form

-

Strength

EQ 500MG VALPROIC ACID

Approval Date

2000-08-04

21168 / 1

Active Ingredient

DIVALPROEX SODIUM

Application Number

21168

Product Number

1

Dosage Form

-

Strength

EQ 500MG VALPROIC ACID

Approval Date

2000-08-04

Regulatory Status

RX

2002
31 May
RX Application: 21168

Drug Name

DEPAKOTE ER

Product Number

2

Dosage Form

-

Strength

EQ 250MG VALPROIC ACID

Approval Date

2002-05-31

21168 / 2

Active Ingredient

DIVALPROEX SODIUM

Application Number

21168

Product Number

2

Dosage Form

-

Strength

EQ 250MG VALPROIC ACID

Approval Date

2002-05-31

Regulatory Status

RX

2015
09 Jan
RX Application: 203952

Drug Name

DUOPA

Product Number

1

Dosage Form

-

Strength

4.63MG/ML;20MG/ML

Approval Date

2015-01-09

203952 / 1

Active Ingredient

CARBIDOPA; LEVODOPA

Application Number

203952

Product Number

1

Dosage Form

-

Strength

4.63MG/ML;20MG/ML

Approval Date

2015-01-09

Regulatory Status

RX

2020
04 Mar
RX Application: 211911

Drug Name

DURYSTA

Product Number

1

Dosage Form

-

Strength

10MCG

Approval Date

2020-03-04

211911 / 1

Active Ingredient

BIMATOPROST

Application Number

211911

Product Number

1

Dosage Form

-

Strength

10MCG

Approval Date

2020-03-04

Regulatory Status

RX

2025
07 Feb
RX Application: 217906

Drug Name

EMBLAVEO

Product Number

1

Dosage Form

-

Strength

EQ 0.5GM BASE/VIAL;1.5GM/VIAL

Approval Date

2025-02-07

217906 / 1

Active Ingredient

AVIBACTAM SODIUM; AZTREONAM

Application Number

217906

Product Number

1

Dosage Form

-

Strength

EQ 0.5GM BASE/VIAL;1.5GM/VIAL

Approval Date

2025-02-07

Regulatory Status

RX

1984
31 Jan
RX Application: 86069

Drug Name

ESTRACE

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

1984-01-31

86069 / 1

Active Ingredient

ESTRADIOL

Application Number

86069

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

1984-01-31

Regulatory Status

RX

2013
25 Jul
RX Application: 204168

Drug Name

FETZIMA

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2013-07-25

204168 / 1

Active Ingredient

LEVOMILNACIPRAN HYDROCHLORIDE

Application Number

204168

Product Number

1

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2013-07-25

Regulatory Status

RX

2013
25 Jul
RX Application: 204168

Drug Name

FETZIMA

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2013-07-25

204168 / 2

Active Ingredient

LEVOMILNACIPRAN HYDROCHLORIDE

Application Number

204168

Product Number

2

Dosage Form

-

Strength

EQ 40MG BASE

Approval Date

2013-07-25

Regulatory Status

RX

2013
25 Jul
RX Application: 204168

Drug Name

FETZIMA

Product Number

3

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2013-07-25

204168 / 3

Active Ingredient

LEVOMILNACIPRAN HYDROCHLORIDE

Application Number

204168

Product Number

3

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2013-07-25

Regulatory Status

RX

2013
25 Jul
RX Application: 204168

Drug Name

FETZIMA

Product Number

4

Dosage Form

-

Strength

EQ 120MG BASE

Approval Date

2013-07-25

204168 / 4

Active Ingredient

LEVOMILNACIPRAN HYDROCHLORIDE

Application Number

204168

Product Number

4

Dosage Form

-

Strength

EQ 120MG BASE

Approval Date

2013-07-25

Regulatory Status

RX

1982
28 Jul
RX Application: 16851

Drug Name

FML

Product Number

2

Dosage Form

-

Strength

0.1%

Approval Date

1982-07-28

16851 / 2

Active Ingredient

FLUOROMETHOLONE

Application Number

16851

Product Number

2

Dosage Form

-

Strength

0.1%

Approval Date

1982-07-28

Regulatory Status

RX

1986
23 Apr
RX Application: 19216

Drug Name

FML FORTE

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1986-04-23

19216 / 1

Active Ingredient

FLUOROMETHOLONE

Application Number

19216

Product Number

1

Dosage Form

-

Strength

0.25%

Approval Date

1986-04-23

Regulatory Status

RX

2000
12 May
RX Application: 65003

Drug Name

GENGRAF

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2000-05-12

65003 / 1

Active Ingredient

CYCLOSPORINE

Application Number

65003

Product Number

1

Dosage Form

-

Strength

25MG

Approval Date

2000-05-12

Regulatory Status

RX

2000
12 May
RX Application: 65003

Drug Name

GENGRAF

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2000-05-12

65003 / 3

Active Ingredient

CYCLOSPORINE

Application Number

65003

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2000-05-12

Regulatory Status

RX

2000
15 Sep
RX Application: 21251

Drug Name

KALETRA

Product Number

1

Dosage Form

-

Strength

80MG/ML;20MG/ML

Approval Date

2000-09-15

21251 / 1

Active Ingredient

LOPINAVIR; RITONAVIR

Application Number

21251

Product Number

1

Dosage Form

-

Strength

80MG/ML;20MG/ML

Approval Date

2000-09-15

Regulatory Status

RX

2005
28 Oct
RX Application: 21906

Drug Name

KALETRA

Product Number

1

Dosage Form

-

Strength

200MG;50MG

Approval Date

2005-10-28

21906 / 1

Active Ingredient

LOPINAVIR; RITONAVIR

Application Number

21906

Product Number

1

Dosage Form

-

Strength

200MG;50MG

Approval Date

2005-10-28

Regulatory Status

RX

2007
09 Nov
RX Application: 21906

Drug Name

KALETRA

Product Number

2

Dosage Form

-

Strength

100MG;25MG

Approval Date

2007-11-09

21906 / 2

Active Ingredient

LOPINAVIR; RITONAVIR

Application Number

21906

Product Number

2

Dosage Form

-

Strength

100MG;25MG

Approval Date

2007-11-09

Regulatory Status

RX

2015
29 Apr
RX Application: 206333

Drug Name

KYBELLA

Product Number

1

Dosage Form

-

Strength

20MG/2ML (10MG/ML)

Approval Date

2015-04-29

206333 / 1

Active Ingredient

DEOXYCHOLIC ACID

Application Number

206333

Product Number

1

Dosage Form

-

Strength

20MG/2ML (10MG/ML)

Approval Date

2015-04-29

Regulatory Status

RX

2008
24 Dec
RX Application: 22369

Drug Name

LATISSE

Product Number

1

Dosage Form

-

Strength

0.03%

Approval Date

2008-12-24

22369 / 1

Active Ingredient

BIMATOPROST

Application Number

22369

Product Number

1

Dosage Form

-

Strength

0.03%

Approval Date

2008-12-24

Regulatory Status

RX

2002
14 Aug
RX Application: 21323

Drug Name

LEXAPRO

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2002-08-14

21323 / 1

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

21323

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2002-08-14

Regulatory Status

RX

2002
14 Aug
RX Application: 21323

Drug Name

LEXAPRO

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2002-08-14

21323 / 2

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

21323

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2002-08-14

Regulatory Status

RX

2002
14 Aug
RX Application: 21323

Drug Name

LEXAPRO

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2002-08-14

21323 / 3

Active Ingredient

ESCITALOPRAM OXALATE

Application Number

21323

Product Number

3

Dosage Form

-

Strength

EQ 20MG BASE

Approval Date

2002-08-14

Regulatory Status

RX

2012
30 Aug
RX Application: 202811

Drug Name

LINZESS

Product Number

1

Dosage Form

-

Strength

145MCG

Approval Date

2012-08-30

202811 / 1

Active Ingredient

LINACLOTIDE

Application Number

202811

Product Number

1

Dosage Form

-

Strength

145MCG

Approval Date

2012-08-30

Regulatory Status

RX

2012
30 Aug
RX Application: 202811

Drug Name

LINZESS

Product Number

2

Dosage Form

-

Strength

290MCG

Approval Date

2012-08-30

202811 / 2

Active Ingredient

LINACLOTIDE

Application Number

202811

Product Number

2

Dosage Form

-

Strength

290MCG

Approval Date

2012-08-30

Regulatory Status

RX

2017
25 Jan
RX Application: 202811

Drug Name

LINZESS

Product Number

3

Dosage Form

-

Strength

72MCG

Approval Date

2017-01-25

202811 / 3

Active Ingredient

LINACLOTIDE

Application Number

202811

Product Number

3

Dosage Form

-

Strength

72MCG

Approval Date

2017-01-25

Regulatory Status

RX

2010
31 Aug
RX Application: 22184

Drug Name

LUMIGAN

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

2010-08-31

22184 / 1

Active Ingredient

BIMATOPROST

Application Number

22184

Product Number

1

Dosage Form

-

Strength

0.01%

Approval Date

2010-08-31

Regulatory Status

RX

1989
26 Jan
RX Application: 19732

Drug Name

LUPRON DEPOT

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

1989-01-26

19732 / 1

Active Ingredient

LEUPROLIDE ACETATE

Application Number

19732

Product Number

1

Dosage Form

-

Strength

7.5MG

Approval Date

1989-01-26

Regulatory Status

RX

1995
26 Oct
RX Application: 20011

Drug Name

LUPRON DEPOT

Product Number

2

Dosage Form

-

Strength

3.75MG

Approval Date

1995-10-26

20011 / 2

Active Ingredient

LEUPROLIDE ACETATE

Application Number

20011

Product Number

2

Dosage Form

-

Strength

3.75MG

Approval Date

1995-10-26

Regulatory Status

RX

1995
22 Dec
RX Application: 20517

Drug Name

LUPRON DEPOT

Product Number

1

Dosage Form

-

Strength

22.5MG

Approval Date

1995-12-22

20517 / 1

Active Ingredient

LEUPROLIDE ACETATE

Application Number

20517

Product Number

1

Dosage Form

-

Strength

22.5MG

Approval Date

1995-12-22

Regulatory Status

RX

1997
30 May
RX Application: 20517

Drug Name

LUPRON DEPOT

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

1997-05-30

20517 / 2

Active Ingredient

LEUPROLIDE ACETATE

Application Number

20517

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

1997-05-30

Regulatory Status

RX

2011
17 Jun
RX Application: 20517

Drug Name

LUPRON DEPOT

Product Number

3

Dosage Form

-

Strength

45MG

Approval Date

2011-06-17

20517 / 3

Active Ingredient

LEUPROLIDE ACETATE

Application Number

20517

Product Number

3

Dosage Form

-

Strength

45MG

Approval Date

2011-06-17

Regulatory Status

RX

1997
07 Mar
RX Application: 20708

Drug Name

LUPRON DEPOT

Product Number

1

Dosage Form

-

Strength

11.25MG

Approval Date

1997-03-07

20708 / 1

Active Ingredient

LEUPROLIDE ACETATE

Application Number

20708

Product Number

1

Dosage Form

-

Strength

11.25MG

Approval Date

1997-03-07

Regulatory Status

RX

1993
16 Apr
RX Application: 20263

Drug Name

LUPRON DEPOT-PED KIT

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

1993-04-16

20263 / 2

Active Ingredient

LEUPROLIDE ACETATE

Application Number

20263

Product Number

2

Dosage Form

-

Strength

7.5MG

Approval Date

1993-04-16

Regulatory Status

RX

1994
21 Jan
RX Application: 20263

Drug Name

LUPRON DEPOT-PED KIT

Product Number

5

Dosage Form

-

Strength

11.25MG

Approval Date

1994-01-21

20263 / 5

Active Ingredient

LEUPROLIDE ACETATE

Application Number

20263

Product Number

5

Dosage Form

-

Strength

11.25MG

Approval Date

1994-01-21

Regulatory Status

RX

1994
21 Jan
RX Application: 20263

Drug Name

LUPRON DEPOT-PED KIT

Product Number

6

Dosage Form

-

Strength

15MG

Approval Date

1994-01-21

20263 / 6

Active Ingredient

LEUPROLIDE ACETATE

Application Number

20263

Product Number

6

Dosage Form

-

Strength

15MG

Approval Date

1994-01-21

Regulatory Status

RX

2011
15 Aug
RX Application: 20263

Drug Name

LUPRON DEPOT-PED KIT

Product Number

7

Dosage Form

-

Strength

11.25MG

Approval Date

2011-08-15

20263 / 7

Active Ingredient

LEUPROLIDE ACETATE

Application Number

20263

Product Number

7

Dosage Form

-

Strength

11.25MG

Approval Date

2011-08-15

Regulatory Status

RX

2011
15 Aug
RX Application: 20263

Drug Name

LUPRON DEPOT-PED KIT

Product Number

8

Dosage Form

-

Strength

30MG

Approval Date

2011-08-15

20263 / 8

Active Ingredient

LEUPROLIDE ACETATE

Application Number

20263

Product Number

8

Dosage Form

-

Strength

30MG

Approval Date

2011-08-15

Regulatory Status

RX

2023
14 Apr
RX Application: 20263

Drug Name

LUPRON DEPOT-PED KIT

Product Number

9

Dosage Form

-

Strength

45MG

Approval Date

2023-04-14

20263 / 9

Active Ingredient

LEUPROLIDE ACETATE

Application Number

20263

Product Number

9

Dosage Form

-

Strength

45MG

Approval Date

2023-04-14

Regulatory Status

RX

2017
03 Aug
RX Application: 209394

Drug Name

MAVYRET

Product Number

1

Dosage Form

-

Strength

100MG;40MG

Approval Date

2017-08-03

209394 / 1

Active Ingredient

GLECAPREVIR; PIBRENTASVIR

Application Number

209394

Product Number

1

Dosage Form

-

Strength

100MG;40MG

Approval Date

2017-08-03

Regulatory Status

RX

2021
10 Jun
RX Application: 215110

Drug Name

MAVYRET

Product Number

1

Dosage Form

-

Strength

50MG/PACKET;20MG/PACKET

Approval Date

2021-06-10

215110 / 1

Active Ingredient

GLECAPREVIR; PIBRENTASVIR

Application Number

215110

Product Number

1

Dosage Form

-

Strength

50MG/PACKET;20MG/PACKET

Approval Date

2021-06-10

Regulatory Status

RX

2014
23 Dec
RX Application: 206439

Drug Name

NAMZARIC

Product Number

1

Dosage Form

-

Strength

10MG;14MG

Approval Date

2014-12-23

206439 / 1

Active Ingredient

DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

Application Number

206439

Product Number

1

Dosage Form

-

Strength

10MG;14MG

Approval Date

2014-12-23

Regulatory Status

RX

2014
23 Dec
RX Application: 206439

Drug Name

NAMZARIC

Product Number

2

Dosage Form

-

Strength

10MG;28MG

Approval Date

2014-12-23

206439 / 2

Active Ingredient

DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

Application Number

206439

Product Number

2

Dosage Form

-

Strength

10MG;28MG

Approval Date

2014-12-23

Regulatory Status

RX

2016
18 Jul
RX Application: 206439

Drug Name

NAMZARIC

Product Number

3

Dosage Form

-

Strength

10MG;7MG

Approval Date

2016-07-18

206439 / 3

Active Ingredient

DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

Application Number

206439

Product Number

3

Dosage Form

-

Strength

10MG;7MG

Approval Date

2016-07-18

Regulatory Status

RX

2016
18 Jul
RX Application: 206439

Drug Name

NAMZARIC

Product Number

4

Dosage Form

-

Strength

10MG;21MG

Approval Date

2016-07-18

206439 / 4

Active Ingredient

DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

Application Number

206439

Product Number

4

Dosage Form

-

Strength

10MG;21MG

Approval Date

2016-07-18

Regulatory Status

RX

2010
10 Feb
RX Application: 22417

Drug Name

NORVIR

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2010-02-10

22417 / 1

Active Ingredient

RITONAVIR

Application Number

22417

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2010-02-10

Regulatory Status

RX

2017
07 Jun
RX Application: 209512

Drug Name

NORVIR

Product Number

1

Dosage Form

-

Strength

100MG/PACKET

Approval Date

2017-06-07

209512 / 1

Active Ingredient

RITONAVIR

Application Number

209512

Product Number

1

Dosage Form

-

Strength

100MG/PACKET

Approval Date

2017-06-07

Regulatory Status

RX

2020
29 May
RX Application: 213388

Drug Name

ORIAHNN (COPACKAGED)

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE

Approval Date

2020-05-29

213388 / 1

Active Ingredient

ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM

Application Number

213388

Product Number

1

Dosage Form

-

Strength

EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE

Approval Date

2020-05-29

Regulatory Status

RX

2018
23 Jul
RX Application: 210450

Drug Name

ORILISSA

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2018-07-23

210450 / 1

Active Ingredient

ELAGOLIX SODIUM

Application Number

210450

Product Number

1

Dosage Form

-

Strength

EQ 150MG BASE

Approval Date

2018-07-23

Regulatory Status

RX

2018
23 Jul
RX Application: 210450

Drug Name

ORILISSA

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2018-07-23

210450 / 2

Active Ingredient

ELAGOLIX SODIUM

Application Number

210450

Product Number

2

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2018-07-23

Regulatory Status

RX

2009
17 Jun
RX Application: 22315

Drug Name

OZURDEX

Product Number

1

Dosage Form

-

Strength

0.7MG

Approval Date

2009-06-17

22315 / 1

Active Ingredient

DEXAMETHASONE

Application Number

22315

Product Number

1

Dosage Form

-

Strength

0.7MG

Approval Date

2009-06-17

Regulatory Status

RX

1982
01 Jan
RX Application: 17011

Drug Name

PRED FORTE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

17011 / 1

Active Ingredient

PREDNISOLONE ACETATE

Application Number

17011

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

1982-01-01

Regulatory Status

RX

1982
01 Jan
RX Application: 17100

Drug Name

PRED MILD

Product Number

1

Dosage Form

-

Strength

0.12%

Approval Date

1982-01-01

17100 / 1

Active Ingredient

PREDNISOLONE ACETATE

Application Number

17100

Product Number

1

Dosage Form

-

Strength

0.12%

Approval Date

1982-01-01

Regulatory Status

RX

2021
28 Sep
RX Application: 215206

Drug Name

QULIPTA

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2021-09-28

215206 / 1

Active Ingredient

ATOGEPANT

Application Number

215206

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2021-09-28

Regulatory Status

RX

2021
28 Sep
RX Application: 215206

Drug Name

QULIPTA

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2021-09-28

215206 / 2

Active Ingredient

ATOGEPANT

Application Number

215206

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2021-09-28

Regulatory Status

RX

2021
28 Sep
RX Application: 215206

Drug Name

QULIPTA

Product Number

3

Dosage Form

-

Strength

60MG

Approval Date

2021-09-28

215206 / 3

Active Ingredient

ATOGEPANT

Application Number

215206

Product Number

3

Dosage Form

-

Strength

60MG

Approval Date

2021-09-28

Regulatory Status

RX

2002
23 Dec
RX Application: 50790

Drug Name

RESTASIS

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2002-12-23

50790 / 1

Active Ingredient

CYCLOSPORINE

Application Number

50790

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2002-12-23

Regulatory Status

RX

2016
27 Oct
RX Application: 50790

Drug Name

RESTASIS MULTIDOSE

Product Number

2

Dosage Form

-

Strength

0.05%

Approval Date

2016-10-27

50790 / 2

Active Ingredient

CYCLOSPORINE

Application Number

50790

Product Number

2

Dosage Form

-

Strength

0.05%

Approval Date

2016-10-27

Regulatory Status

RX

2019
16 Aug
RX Application: 211675

Drug Name

RINVOQ

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2019-08-16

211675 / 1

Active Ingredient

UPADACITINIB

Application Number

211675

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2019-08-16

Regulatory Status

RX

2022
14 Jan
RX Application: 211675

Drug Name

RINVOQ

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2022-01-14

211675 / 2

Active Ingredient

UPADACITINIB

Application Number

211675

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2022-01-14

Regulatory Status

RX

2022
16 Mar
RX Application: 211675

Drug Name

RINVOQ

Product Number

3

Dosage Form

-

Strength

45MG

Approval Date

2022-03-16

211675 / 3

Active Ingredient

UPADACITINIB

Application Number

211675

Product Number

3

Dosage Form

-

Strength

45MG

Approval Date

2022-03-16

Regulatory Status

RX

2024
26 Apr
RX Application: 218347

Drug Name

RINVOQ LQ

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2024-04-26

218347 / 1

Active Ingredient

UPADACITINIB

Application Number

218347

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2024-04-26

Regulatory Status

RX

2009
13 Aug
RX Application: 22117

Drug Name

SAPHRIS

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2009-08-13

22117 / 1

Active Ingredient

ASENAPINE MALEATE

Application Number

22117

Product Number

1

Dosage Form

-

Strength

EQ 5MG BASE

Approval Date

2009-08-13

Regulatory Status

RX

2009
13 Aug
RX Application: 22117

Drug Name

SAPHRIS

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2009-08-13

22117 / 2

Active Ingredient

ASENAPINE MALEATE

Application Number

22117

Product Number

2

Dosage Form

-

Strength

EQ 10MG BASE

Approval Date

2009-08-13

Regulatory Status

RX

2015
12 Mar
RX Application: 22117

Drug Name

SAPHRIS

Product Number

3

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2015-03-12

22117 / 3

Active Ingredient

ASENAPINE MALEATE

Application Number

22117

Product Number

3

Dosage Form

-

Strength

EQ 2.5MG BASE

Approval Date

2015-03-12

Regulatory Status

RX

2009
14 Jan
RX Application: 22256

Drug Name

SAVELLA

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2009-01-14

22256 / 1

Active Ingredient

MILNACIPRAN HYDROCHLORIDE

Application Number

22256

Product Number

1

Dosage Form

-

Strength

12.5MG

Approval Date

2009-01-14

Regulatory Status

RX

2009
14 Jan
RX Application: 22256

Drug Name

SAVELLA

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2009-01-14

22256 / 2

Active Ingredient

MILNACIPRAN HYDROCHLORIDE

Application Number

22256

Product Number

2

Dosage Form

-

Strength

25MG

Approval Date

2009-01-14

Regulatory Status

RX

2009
14 Jan
RX Application: 22256

Drug Name

SAVELLA

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2009-01-14

22256 / 3

Active Ingredient

MILNACIPRAN HYDROCHLORIDE

Application Number

22256

Product Number

3

Dosage Form

-

Strength

50MG

Approval Date

2009-01-14

Regulatory Status

RX

2009
14 Jan
RX Application: 22256

Drug Name

SAVELLA

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2009-01-14

22256 / 4

Active Ingredient

MILNACIPRAN HYDROCHLORIDE

Application Number

22256

Product Number

4

Dosage Form

-

Strength

100MG

Approval Date

2009-01-14

Regulatory Status

RX

2002
24 Jul
RX Application: 21402

Drug Name

SYNTHROID

Product Number

1

Dosage Form

-

Strength

0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-07-24

21402 / 1

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21402

Product Number

1

Dosage Form

-

Strength

0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-07-24

Regulatory Status

RX

2002
24 Jul
RX Application: 21402

Drug Name

SYNTHROID

Product Number

2

Dosage Form

-

Strength

0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-07-24

21402 / 2

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21402

Product Number

2

Dosage Form

-

Strength

0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-07-24

Regulatory Status

RX

2002
24 Jul
RX Application: 21402

Drug Name

SYNTHROID

Product Number

3

Dosage Form

-

Strength

0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-07-24

21402 / 3

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21402

Product Number

3

Dosage Form

-

Strength

0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-07-24

Regulatory Status

RX

2002
24 Jul
RX Application: 21402

Drug Name

SYNTHROID

Product Number

4

Dosage Form

-

Strength

0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-07-24

21402 / 4

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21402

Product Number

4

Dosage Form

-

Strength

0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-07-24

Regulatory Status

RX

2002
24 Jul
RX Application: 21402

Drug Name

SYNTHROID

Product Number

5

Dosage Form

-

Strength

0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-07-24

21402 / 5

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21402

Product Number

5

Dosage Form

-

Strength

0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-07-24

Regulatory Status

RX

2002
24 Jul
RX Application: 21402

Drug Name

SYNTHROID

Product Number

6

Dosage Form

-

Strength

0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-07-24

21402 / 6

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21402

Product Number

6

Dosage Form

-

Strength

0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-07-24

Regulatory Status

RX

2002
24 Jul
RX Application: 21402

Drug Name

SYNTHROID

Product Number

7

Dosage Form

-

Strength

0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-07-24

21402 / 7

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21402

Product Number

7

Dosage Form

-

Strength

0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-07-24

Regulatory Status

RX

2002
24 Jul
RX Application: 21402

Drug Name

SYNTHROID

Product Number

8

Dosage Form

-

Strength

0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-07-24

21402 / 8

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21402

Product Number

8

Dosage Form

-

Strength

0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-07-24

Regulatory Status

RX

2002
24 Jul
RX Application: 21402

Drug Name

SYNTHROID

Product Number

9

Dosage Form

-

Strength

0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-07-24

21402 / 9

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21402

Product Number

9

Dosage Form

-

Strength

0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-07-24

Regulatory Status

RX

2002
24 Jul
RX Application: 21402

Drug Name

SYNTHROID

Product Number

10

Dosage Form

-

Strength

0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-07-24

21402 / 10

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21402

Product Number

10

Dosage Form

-

Strength

0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-07-24

Regulatory Status

RX

2002
24 Jul
RX Application: 21402

Drug Name

SYNTHROID

Product Number

11

Dosage Form

-

Strength

0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-07-24

21402 / 11

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21402

Product Number

11

Dosage Form

-

Strength

0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-07-24

Regulatory Status

RX

2002
24 Jul
RX Application: 21402

Drug Name

SYNTHROID

Product Number

12

Dosage Form

-

Strength

0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-07-24

21402 / 12

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

21402

Product Number

12

Dosage Form

-

Strength

0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium

Approval Date

2002-07-24

Regulatory Status

RX

2010
29 Oct
RX Application: 200327

Drug Name

TEFLARO

Product Number

1

Dosage Form

-

Strength

400MG/VIAL

Approval Date

2010-10-29

200327 / 1

Active Ingredient

CEFTAROLINE FOSAMIL

Application Number

200327

Product Number

1

Dosage Form

-

Strength

400MG/VIAL

Approval Date

2010-10-29

Regulatory Status

RX

2010
29 Oct
RX Application: 200327

Drug Name

TEFLARO

Product Number

2

Dosage Form

-

Strength

600MG/VIAL

Approval Date

2010-10-29

200327 / 2

Active Ingredient

CEFTAROLINE FOSAMIL

Application Number

200327

Product Number

2

Dosage Form

-

Strength

600MG/VIAL

Approval Date

2010-10-29

Regulatory Status

RX

2019
23 Dec
RX Application: 211765

Drug Name

UBRELVY

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2019-12-23

211765 / 1

Active Ingredient

UBROGEPANT

Application Number

211765

Product Number

1

Dosage Form

-

Strength

50MG

Approval Date

2019-12-23

Regulatory Status

RX

2019
23 Dec
RX Application: 211765

Drug Name

UBRELVY

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2019-12-23

211765 / 2

Active Ingredient

UBROGEPANT

Application Number

211765

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2019-12-23

Regulatory Status

RX

1995
07 Jun
RX Application: 20478

Drug Name

ULTANE

Product Number

1

Dosage Form

-

Strength

100%

Approval Date

1995-06-07

20478 / 1

Active Ingredient

SEVOFLURANE

Application Number

20478

Product Number

1

Dosage Form

-

Strength

100%

Approval Date

1995-06-07

Regulatory Status

RX

2016
11 Apr
RX Application: 208573

Drug Name

VENCLEXTA

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2016-04-11

208573 / 1

Active Ingredient

VENETOCLAX

Application Number

208573

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2016-04-11

Regulatory Status

RX

2016
11 Apr
RX Application: 208573

Drug Name

VENCLEXTA

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2016-04-11

208573 / 2

Active Ingredient

VENETOCLAX

Application Number

208573

Product Number

2

Dosage Form

-

Strength

50MG

Approval Date

2016-04-11

Regulatory Status

RX

2016
11 Apr
RX Application: 208573

Drug Name

VENCLEXTA

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2016-04-11

208573 / 3

Active Ingredient

VENETOCLAX

Application Number

208573

Product Number

3

Dosage Form

-

Strength

100MG

Approval Date

2016-04-11

Regulatory Status

RX

2015
27 May
RX Application: 206940

Drug Name

VIBERZI

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2015-05-27

206940 / 1

Active Ingredient

ELUXADOLINE

Application Number

206940

Product Number

1

Dosage Form

-

Strength

75MG

Approval Date

2015-05-27

Regulatory Status

RX

2015
27 May
RX Application: 206940

Drug Name

VIBERZI

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2015-05-27

206940 / 2

Active Ingredient

ELUXADOLINE

Application Number

206940

Product Number

2

Dosage Form

-

Strength

100MG

Approval Date

2015-05-27

Regulatory Status

RX

2011
21 Jan
RX Application: 22567

Drug Name

VIIBRYD

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2011-01-21

22567 / 1

Active Ingredient

VILAZODONE HYDROCHLORIDE

Application Number

22567

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2011-01-21

Regulatory Status

RX

2011
21 Jan
RX Application: 22567

Drug Name

VIIBRYD

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2011-01-21

22567 / 2

Active Ingredient

VILAZODONE HYDROCHLORIDE

Application Number

22567

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2011-01-21

Regulatory Status

RX

2011
21 Jan
RX Application: 22567

Drug Name

VIIBRYD

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2011-01-21

22567 / 3

Active Ingredient

VILAZODONE HYDROCHLORIDE

Application Number

22567

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2011-01-21

Regulatory Status

RX

2015
17 Sep
RX Application: 204370

Drug Name

VRAYLAR

Product Number

1

Dosage Form

-

Strength

EQ 1.5MG BASE

Approval Date

2015-09-17

204370 / 1

Active Ingredient

CARIPRAZINE HYDROCHLORIDE

Application Number

204370

Product Number

1

Dosage Form

-

Strength

EQ 1.5MG BASE

Approval Date

2015-09-17

Regulatory Status

RX

2015
17 Sep
RX Application: 204370

Drug Name

VRAYLAR

Product Number

2

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2015-09-17

204370 / 2

Active Ingredient

CARIPRAZINE HYDROCHLORIDE

Application Number

204370

Product Number

2

Dosage Form

-

Strength

EQ 3MG BASE

Approval Date

2015-09-17

Regulatory Status

RX

2015
17 Sep
RX Application: 204370

Drug Name

VRAYLAR

Product Number

3

Dosage Form

-

Strength

EQ 4.5MG BASE

Approval Date

2015-09-17

204370 / 3

Active Ingredient

CARIPRAZINE HYDROCHLORIDE

Application Number

204370

Product Number

3

Dosage Form

-

Strength

EQ 4.5MG BASE

Approval Date

2015-09-17

Regulatory Status

RX

2015
17 Sep
RX Application: 204370

Drug Name

VRAYLAR

Product Number

4

Dosage Form

-

Strength

EQ 6MG BASE

Approval Date

2015-09-17

204370 / 4

Active Ingredient

CARIPRAZINE HYDROCHLORIDE

Application Number

204370

Product Number

4

Dosage Form

-

Strength

EQ 6MG BASE

Approval Date

2015-09-17

Regulatory Status

RX

2025
18 Dec
RX Application: 204370

Drug Name

VRAYLAR

Product Number

5

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2025-12-18

204370 / 5

Active Ingredient

CARIPRAZINE HYDROCHLORIDE

Application Number

204370

Product Number

5

Dosage Form

-

Strength

EQ 0.5MG BASE

Approval Date

2025-12-18

Regulatory Status

RX

2025
18 Dec
RX Application: 204370

Drug Name

VRAYLAR

Product Number

6

Dosage Form

-

Strength

EQ 0.75MG BASE

Approval Date

2025-12-18

204370 / 6

Active Ingredient

CARIPRAZINE HYDROCHLORIDE

Application Number

204370

Product Number

6

Dosage Form

-

Strength

EQ 0.75MG BASE

Approval Date

2025-12-18

Regulatory Status

RX

2024
16 Oct
RX Application: 216962

Drug Name

VYALEV

Product Number

1

Dosage Form

-

Strength

120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)

Approval Date

2024-10-16

216962 / 1

Active Ingredient

FOSCARBIDOPA; FOSLEVODOPA

Application Number

216962

Product Number

1

Dosage Form

-

Strength

120MG/10ML;2400MG/10ML (12MG/ML;240MG/ML)

Approval Date

2024-10-16

Regulatory Status

RX

1998
17 Apr
RX Application: 20819

Drug Name

ZEMPLAR

Product Number

1

Dosage Form

-

Strength

0.005MG/ML (0.005MG/ML)

Approval Date

1998-04-17

20819 / 1

Active Ingredient

PARICALCITOL

Application Number

20819

Product Number

1

Dosage Form

-

Strength

0.005MG/ML (0.005MG/ML)

Approval Date

1998-04-17

Regulatory Status

RX

2000
01 Feb
RX Application: 20819

Drug Name

ZEMPLAR

Product Number

2

Dosage Form

-

Strength

0.002MG/ML (0.002MG/ML)

Approval Date

2000-02-01

20819 / 2

Active Ingredient

PARICALCITOL

Application Number

20819

Product Number

2

Dosage Form

-

Strength

0.002MG/ML (0.002MG/ML)

Approval Date

2000-02-01

Regulatory Status

RX

2000
01 Feb
RX Application: 20819

Drug Name

ZEMPLAR

Product Number

3

Dosage Form

-

Strength

0.01MG/2ML (0.005MG/ML)

Approval Date

2000-02-01

20819 / 3

Active Ingredient

PARICALCITOL

Application Number

20819

Product Number

3

Dosage Form

-

Strength

0.01MG/2ML (0.005MG/ML)

Approval Date

2000-02-01

Regulatory Status

RX

2010
18 May
RX Application: 22548

Drug Name

ZYMAXID

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2010-05-18

22548 / 1

Active Ingredient

GATIFLOXACIN

Application Number

22548

Product Number

1

Dosage Form

-

Strength

0.5%

Approval Date

2010-05-18

Regulatory Status

RX

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Drug Status Breakdown
122 total
  • RX
Official Source

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

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FDA Approved Drug Record Details Preview

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

Drug Name

ACULAR

Application Number

19700

Product Number

1

Active Ingredient

KETOROLAC TROMETHAMINE

Dosage Form

-

Strength

0.5%

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

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Organized FDA drug records

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