Xiromed
FDA Approved Drugs

Xiromed

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 OTC
  • Total Records 99
  • Latest Approval Date Nov 20, 2025
  • Data Source FDA
  • First Approval Date Aug 03, 2010
All
99
View
Discontinued
19
View
OTC
2
View
RX
78
View
Company Overview

Company

Xiromed

Country

U.S.A

Website

Visit Website

Email

Social Profiles

Company Snapshot

Xiromed

180 Park Ave ,Suite 101 Florham Park, NJ 07932

U.S.A

xiromed.com/usa/ View on Map
FDA Approved Drug Records ( 99 records )
2020
29 Jan
RX Application: 201501

Drug Name

ACYCLOVIR

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2020-01-29

201501 / 1

Active Ingredient

ACYCLOVIR

Application Number

201501

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2020-01-29

Regulatory Status

RX

2010
03 Aug
RX Application: 79102

Drug Name

ALTAVERA

Product Number

1

Dosage Form

-

Strength

0.03MG;0.15MG

Approval Date

2010-08-03

79102 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

79102

Product Number

1

Dosage Form

-

Strength

0.03MG;0.15MG

Approval Date

2010-08-03

Regulatory Status

RX

2023
18 Apr
RX Application: 210639

Drug Name

BETAMETHASONE VALERATE

Product Number

1

Dosage Form

-

Strength

0.12%

Approval Date

2023-04-18

210639 / 1

Active Ingredient

BETAMETHASONE VALERATE

Application Number

210639

Product Number

1

Dosage Form

-

Strength

0.12%

Approval Date

2023-04-18

Regulatory Status

RX

2025
03 Jun
RX Application: 218061

Drug Name

CETRORELIX ACETATE

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE/VIAL

Approval Date

2025-06-03

218061 / 1

Active Ingredient

CETRORELIX ACETATE

Application Number

218061

Product Number

1

Dosage Form

-

Strength

EQ 0.25MG BASE/VIAL

Approval Date

2025-06-03

Regulatory Status

RX

2018
17 Apr
RX Application: 209701

Drug Name

CLOBETASOL PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2018-04-17

209701 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

209701

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2018-04-17

Regulatory Status

RX

2018
15 Jun
RX Application: 210034

Drug Name

CLOBETASOL PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2018-06-15

210034 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

210034

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2018-06-15

Regulatory Status

RX

2025
20 Nov
RX Application: 210638

Drug Name

CLOBETASOL PROPIONATE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2025-11-20

210638 / 1

Active Ingredient

CLOBETASOL PROPIONATE

Application Number

210638

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2025-11-20

Regulatory Status

RX

2021
20 Aug
Discontinued Application: 215046

Drug Name

CYANOCOBALAMIN

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2021-08-20

215046 / 1

Active Ingredient

CYANOCOBALAMIN

Application Number

215046

Product Number

1

Dosage Form

-

Strength

1MG/ML

Approval Date

2021-08-20

Regulatory Status

Discontinued

2019
22 Oct
Discontinued Application: 209571

Drug Name

DARIFENACIN HYDROBROMIDE

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

2019-10-22

209571 / 1

Active Ingredient

DARIFENACIN HYDROBROMIDE

Application Number

209571

Product Number

1

Dosage Form

-

Strength

EQ 15MG BASE

Approval Date

2019-10-22

Regulatory Status

Discontinued

2019
22 Oct
Discontinued Application: 209571

Drug Name

DARIFENACIN HYDROBROMIDE

Product Number

2

Dosage Form

-

Strength

EQ 7.5MG BASE

Approval Date

2019-10-22

209571 / 2

Active Ingredient

DARIFENACIN HYDROBROMIDE

Application Number

209571

Product Number

2

Dosage Form

-

Strength

EQ 7.5MG BASE

Approval Date

2019-10-22

Regulatory Status

Discontinued

2015
20 May
Discontinued Application: 202085

Drug Name

DESOGESTREL AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.15MG;0.03MG

Approval Date

2015-05-20

202085 / 1

Active Ingredient

DESOGESTREL; ETHINYL ESTRADIOL

Application Number

202085

Product Number

1

Dosage Form

-

Strength

0.15MG;0.03MG

Approval Date

2015-05-20

Regulatory Status

Discontinued

2013
30 Aug
RX Application: 202296

Drug Name

DESOGESTREL AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.15MG,N/A;0.02MG,0.01MG

Approval Date

2013-08-30

202296 / 1

Active Ingredient

DESOGESTREL; ETHINYL ESTRADIOL

Application Number

202296

Product Number

1

Dosage Form

-

Strength

0.15MG,N/A;0.02MG,0.01MG

Approval Date

2013-08-30

Regulatory Status

RX

2015
04 May
RX Application: 202131

Drug Name

DROSPIRENONE AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

3MG;0.03MG

Approval Date

2015-05-04

202131 / 1

Active Ingredient

DROSPIRENONE; ETHINYL ESTRADIOL

Application Number

202131

Product Number

1

Dosage Form

-

Strength

3MG;0.03MG

Approval Date

2015-05-04

Regulatory Status

RX

2015
22 Oct
RX Application: 202594

Drug Name

DROSPIRENONE AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

3MG;0.02MG

Approval Date

2015-10-22

202594 / 1

Active Ingredient

DROSPIRENONE; ETHINYL ESTRADIOL

Application Number

202594

Product Number

1

Dosage Form

-

Strength

3MG;0.02MG

Approval Date

2015-10-22

Regulatory Status

RX

2015
04 Dec
Discontinued Application: 202507

Drug Name

ELIFEMME

Product Number

1

Dosage Form

-

Strength

0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG

Approval Date

2015-12-04

202507 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

202507

Product Number

1

Dosage Form

-

Strength

0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG

Approval Date

2015-12-04

Regulatory Status

Discontinued

2023
29 Jun
RX Application: 211157

Drug Name

ENILLORING

Product Number

1

Dosage Form

-

Strength

0.015MG/24HR;0.12MG/24HR

Approval Date

2023-06-29

211157 / 1

Active Ingredient

ETHINYL ESTRADIOL; ETONOGESTREL

Application Number

211157

Product Number

1

Dosage Form

-

Strength

0.015MG/24HR;0.12MG/24HR

Approval Date

2023-06-29

Regulatory Status

RX

2022
21 Apr
RX Application: 215825

Drug Name

EPHEDRINE SULFATE

Product Number

1

Dosage Form

-

Strength

50MG/ML (50MG/ML)

Approval Date

2022-04-21

215825 / 1

Active Ingredient

EPHEDRINE SULFATE

Application Number

215825

Product Number

1

Dosage Form

-

Strength

50MG/ML (50MG/ML)

Approval Date

2022-04-21

Regulatory Status

RX

2013
30 Jan
RX Application: 90794

Drug Name

ESTARYLLA

Product Number

1

Dosage Form

-

Strength

0.035MG;0.25MG

Approval Date

2013-01-30

90794 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORGESTIMATE

Application Number

90794

Product Number

1

Dosage Form

-

Strength

0.035MG;0.25MG

Approval Date

2013-01-30

Regulatory Status

RX

2022
10 Aug
RX Application: 211783

Drug Name

ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.1% (0.25GM/PACKET)

Approval Date

2022-08-10

211783 / 1

Active Ingredient

ESTRADIOL

Application Number

211783

Product Number

1

Dosage Form

-

Strength

0.1% (0.25GM/PACKET)

Approval Date

2022-08-10

Regulatory Status

RX

2022
10 Aug
RX Application: 211783

Drug Name

ESTRADIOL

Product Number

2

Dosage Form

-

Strength

0.1% (0.5GM/PACKET)

Approval Date

2022-08-10

211783 / 2

Active Ingredient

ESTRADIOL

Application Number

211783

Product Number

2

Dosage Form

-

Strength

0.1% (0.5GM/PACKET)

Approval Date

2022-08-10

Regulatory Status

RX

2022
10 Aug
RX Application: 211783

Drug Name

ESTRADIOL

Product Number

3

Dosage Form

-

Strength

0.1% (1GM/PACKET)

Approval Date

2022-08-10

211783 / 3

Active Ingredient

ESTRADIOL

Application Number

211783

Product Number

3

Dosage Form

-

Strength

0.1% (1GM/PACKET)

Approval Date

2022-08-10

Regulatory Status

RX

2017
10 Feb
RX Application: 207261

Drug Name

ESTRADIOL AND NORETHINDRONE ACETATE

Product Number

1

Dosage Form

-

Strength

0.5MG;0.1MG

Approval Date

2017-02-10

207261 / 1

Active Ingredient

ESTRADIOL; NORETHINDRONE ACETATE

Application Number

207261

Product Number

1

Dosage Form

-

Strength

0.5MG;0.1MG

Approval Date

2017-02-10

Regulatory Status

RX

2017
10 Feb
RX Application: 207261

Drug Name

ESTRADIOL AND NORETHINDRONE ACETATE

Product Number

2

Dosage Form

-

Strength

1MG;0.5MG

Approval Date

2017-02-10

207261 / 2

Active Ingredient

ESTRADIOL; NORETHINDRONE ACETATE

Application Number

207261

Product Number

2

Dosage Form

-

Strength

1MG;0.5MG

Approval Date

2017-02-10

Regulatory Status

RX

2023
28 Apr
RX Application: 216656

Drug Name

ESTRADIOL VALERATE

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2023-04-28

216656 / 1

Active Ingredient

ESTRADIOL VALERATE

Application Number

216656

Product Number

1

Dosage Form

-

Strength

10MG/ML

Approval Date

2023-04-28

Regulatory Status

RX

2023
28 Apr
RX Application: 216656

Drug Name

ESTRADIOL VALERATE

Product Number

2

Dosage Form

-

Strength

20MG/ML

Approval Date

2023-04-28

216656 / 2

Active Ingredient

ESTRADIOL VALERATE

Application Number

216656

Product Number

2

Dosage Form

-

Strength

20MG/ML

Approval Date

2023-04-28

Regulatory Status

RX

2023
28 Apr
RX Application: 216656

Drug Name

ESTRADIOL VALERATE

Product Number

3

Dosage Form

-

Strength

40MG/ML

Approval Date

2023-04-28

216656 / 3

Active Ingredient

ESTRADIOL VALERATE

Application Number

216656

Product Number

3

Dosage Form

-

Strength

40MG/ML

Approval Date

2023-04-28

Regulatory Status

RX

2016
28 Jul
RX Application: 204703

Drug Name

ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.035MG;1MG

Approval Date

2016-07-28

204703 / 1

Active Ingredient

ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE

Application Number

204703

Product Number

1

Dosage Form

-

Strength

0.035MG;1MG

Approval Date

2016-07-28

Regulatory Status

RX

2016
09 Feb
RX Application: 204704

Drug Name

ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.05MG;1MG

Approval Date

2016-02-09

204704 / 1

Active Ingredient

ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE

Application Number

204704

Product Number

1

Dosage Form

-

Strength

0.05MG;1MG

Approval Date

2016-02-09

Regulatory Status

RX

2019
26 Nov
RX Application: 212976

Drug Name

FLUOCINONIDE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2019-11-26

212976 / 1

Active Ingredient

FLUOCINONIDE

Application Number

212976

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2019-11-26

Regulatory Status

RX

2020
06 Oct
RX Application: 212548

Drug Name

FOSFOMYCIN TROMETHAMINE

Product Number

1

Dosage Form

-

Strength

EQ 3GM BASE/PACKET

Approval Date

2020-10-06

212548 / 1

Active Ingredient

FOSFOMYCIN TROMETHAMINE

Application Number

212548

Product Number

1

Dosage Form

-

Strength

EQ 3GM BASE/PACKET

Approval Date

2020-10-06

Regulatory Status

RX

2021
13 Aug
RX Application: 213553

Drug Name

FULVESTRANT

Product Number

1

Dosage Form

-

Strength

250MG/5ML (50MG/ML)

Approval Date

2021-08-13

213553 / 1

Active Ingredient

FULVESTRANT

Application Number

213553

Product Number

1

Dosage Form

-

Strength

250MG/5ML (50MG/ML)

Approval Date

2021-08-13

Regulatory Status

RX

2020
09 Nov
RX Application: 213317

Drug Name

GEMMILY

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG

Approval Date

2020-11-09

213317 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

213317

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG

Approval Date

2020-11-09

Regulatory Status

RX

2021
04 Mar
Discontinued Application: 212227

Drug Name

GLYCOPYRROLATE

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

2021-03-04

212227 / 1

Active Ingredient

GLYCOPYRROLATE

Application Number

212227

Product Number

1

Dosage Form

-

Strength

0.2MG/ML

Approval Date

2021-03-04

Regulatory Status

Discontinued

2024
23 Feb
RX Application: 218326

Drug Name

GUANFACINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2024-02-23

218326 / 1

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

218326

Product Number

1

Dosage Form

-

Strength

EQ 1MG BASE

Approval Date

2024-02-23

Regulatory Status

RX

2024
23 Feb
RX Application: 218326

Drug Name

GUANFACINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2024-02-23

218326 / 2

Active Ingredient

GUANFACINE HYDROCHLORIDE

Application Number

218326

Product Number

2

Dosage Form

-

Strength

EQ 2MG BASE

Approval Date

2024-02-23

Regulatory Status

RX

2010
27 Sep
RX Application: 79064

Drug Name

INTROVALE

Product Number

1

Dosage Form

-

Strength

0.03MG;0.15MG

Approval Date

2010-09-27

79064 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

79064

Product Number

1

Dosage Form

-

Strength

0.03MG;0.15MG

Approval Date

2010-09-27

Regulatory Status

RX

2015
12 Aug
RX Application: 202789

Drug Name

ISIBLOOM

Product Number

1

Dosage Form

-

Strength

0.15MG;0.03MG

Approval Date

2015-08-12

202789 / 1

Active Ingredient

DESOGESTREL; ETHINYL ESTRADIOL

Application Number

202789

Product Number

1

Dosage Form

-

Strength

0.15MG;0.03MG

Approval Date

2015-08-12

Regulatory Status

RX

2017
27 Dec
RX Application: 203770

Drug Name

JAIMIESS

Product Number

1

Dosage Form

-

Strength

0.03MG,0.01MG;0.15MG,N/A

Approval Date

2017-12-27

203770 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

203770

Product Number

1

Dosage Form

-

Strength

0.03MG,0.01MG;0.15MG,N/A

Approval Date

2017-12-27

Regulatory Status

RX

2021
21 May
RX Application: 213601

Drug Name

KETOCONAZOLE

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2021-05-21

213601 / 1

Active Ingredient

KETOCONAZOLE

Application Number

213601

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2021-05-21

Regulatory Status

RX

2016
25 Jul
RX Application: 203203

Drug Name

LANSOPRAZOLE

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2016-07-25

203203 / 1

Active Ingredient

LANSOPRAZOLE

Application Number

203203

Product Number

1

Dosage Form

-

Strength

15MG

Approval Date

2016-07-25

Regulatory Status

RX

2016
25 Jul
RX Application: 203203

Drug Name

LANSOPRAZOLE

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2016-07-25

203203 / 2

Active Ingredient

LANSOPRAZOLE

Application Number

203203

Product Number

2

Dosage Form

-

Strength

30MG

Approval Date

2016-07-25

Regulatory Status

RX

2014
31 Oct
OTC Application: 202739

Drug Name

LEVONORGESTREL

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

2014-10-31

202739 / 1

Active Ingredient

LEVONORGESTREL

Application Number

202739

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

2014-10-31

Regulatory Status

OTC

2016
02 Sep
Discontinued Application: 202740

Drug Name

LEVONORGESTREL

Product Number

1

Dosage Form

-

Strength

0.75MG

Approval Date

2016-09-02

202740 / 1

Active Ingredient

LEVONORGESTREL

Application Number

202740

Product Number

1

Dosage Form

-

Strength

0.75MG

Approval Date

2016-09-02

Regulatory Status

Discontinued

2018
18 Sep
OTC Application: 205329

Drug Name

LEVONORGESTREL

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

2018-09-18

205329 / 1

Active Ingredient

LEVONORGESTREL

Application Number

205329

Product Number

1

Dosage Form

-

Strength

1.5MG

Approval Date

2018-09-18

Regulatory Status

OTC

2012
21 Dec
RX Application: 91663

Drug Name

LEVONORGESTREL AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.03MG;0.15MG

Approval Date

2012-12-21

91663 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

91663

Product Number

1

Dosage Form

-

Strength

0.03MG;0.15MG

Approval Date

2012-12-21

Regulatory Status

RX

2013
09 Oct
RX Application: 200245

Drug Name

LEVONORGESTREL AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.02MG;0.1MG

Approval Date

2013-10-09

200245 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

200245

Product Number

1

Dosage Form

-

Strength

0.02MG;0.1MG

Approval Date

2013-10-09

Regulatory Status

RX

2015
21 Apr
RX Application: 200490

Drug Name

LEVONORGESTREL AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.03MG;0.15MG

Approval Date

2015-04-21

200490 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

200490

Product Number

1

Dosage Form

-

Strength

0.03MG;0.15MG

Approval Date

2015-04-21

Regulatory Status

RX

2014
08 Dec
Discontinued Application: 202247

Drug Name

LEVONORGESTREL AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.02MG;0.1MG

Approval Date

2014-12-08

202247 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

202247

Product Number

1

Dosage Form

-

Strength

0.02MG;0.1MG

Approval Date

2014-12-08

Regulatory Status

Discontinued

2018
23 Mar
Discontinued Application: 202970

Drug Name

LEVONORGESTREL AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG

Approval Date

2018-03-23

202970 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

202970

Product Number

1

Dosage Form

-

Strength

0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.125MG

Approval Date

2018-03-23

Regulatory Status

Discontinued

2015
27 May
RX Application: 200492

Drug Name

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.03MG,0.01MG;0.15MG,N/A

Approval Date

2015-05-27

200492 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

200492

Product Number

1

Dosage Form

-

Strength

0.03MG,0.01MG;0.15MG,N/A

Approval Date

2015-05-27

Regulatory Status

RX

2015
17 Jun
RX Application: 200493

Drug Name

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.02MG,0.1MG;0.01MG,N/A

Approval Date

2015-06-17

200493 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

200493

Product Number

1

Dosage Form

-

Strength

0.02MG,0.1MG;0.01MG,N/A

Approval Date

2015-06-17

Regulatory Status

RX

2017
14 Dec
RX Application: 205131

Drug Name

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.02MG,0.1MG;0.01MG,N/A

Approval Date

2017-12-14

205131 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

205131

Product Number

1

Dosage Form

-

Strength

0.02MG,0.1MG;0.01MG,N/A

Approval Date

2017-12-14

Regulatory Status

RX

2017
02 Oct
RX Application: 206053

Drug Name

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A

Approval Date

2017-10-02

206053 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

206053

Product Number

1

Dosage Form

-

Strength

0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A

Approval Date

2017-10-02

Regulatory Status

RX

2023
16 Aug
RX Application: 214640

Drug Name

LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Product Number

1

Dosage Form

-

Strength

0.02MG;0.1MG

Approval Date

2023-08-16

214640 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

214640

Product Number

1

Dosage Form

-

Strength

0.02MG;0.1MG

Approval Date

2023-08-16

Regulatory Status

RX

2024
29 Nov
RX Application: 217495

Drug Name

LEVOTHYROXINE SODIUM

Product Number

1

Dosage Form

-

Strength

100MCG/VIAL

Approval Date

2024-11-29

217495 / 1

Active Ingredient

LEVOTHYROXINE SODIUM

Application Number

217495

Product Number

1

Dosage Form

-

Strength

100MCG/VIAL

Approval Date

2024-11-29

Regulatory Status

RX

2011
28 Mar
RX Application: 79221

Drug Name

LORYNA

Product Number

1

Dosage Form

-

Strength

3MG;0.02MG

Approval Date

2011-03-28

79221 / 1

Active Ingredient

DROSPIRENONE; ETHINYL ESTRADIOL

Application Number

79221

Product Number

1

Dosage Form

-

Strength

3MG;0.02MG

Approval Date

2011-03-28

Regulatory Status

RX

2018
12 Oct
RX Application: 210227

Drug Name

MEDROXYPROGESTERONE ACETATE

Product Number

1

Dosage Form

-

Strength

150MG/ML

Approval Date

2018-10-12

210227 / 1

Active Ingredient

MEDROXYPROGESTERONE ACETATE

Application Number

210227

Product Number

1

Dosage Form

-

Strength

150MG/ML

Approval Date

2018-10-12

Regulatory Status

RX

2025
30 Jul
RX Application: 219363

Drug Name

METHYLENE BLUE

Product Number

1

Dosage Form

-

Strength

50MG/10ML (5MG/ML)

Approval Date

2025-07-30

219363 / 1

Active Ingredient

METHYLENE BLUE

Application Number

219363

Product Number

1

Dosage Form

-

Strength

50MG/10ML (5MG/ML)

Approval Date

2025-07-30

Regulatory Status

RX

2020
01 Oct
RX Application: 207849

Drug Name

MIDODRINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2020-10-01

207849 / 1

Active Ingredient

MIDODRINE HYDROCHLORIDE

Application Number

207849

Product Number

1

Dosage Form

-

Strength

2.5MG

Approval Date

2020-10-01

Regulatory Status

RX

2020
01 Oct
RX Application: 207849

Drug Name

MIDODRINE HYDROCHLORIDE

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2020-10-01

207849 / 2

Active Ingredient

MIDODRINE HYDROCHLORIDE

Application Number

207849

Product Number

2

Dosage Form

-

Strength

5MG

Approval Date

2020-10-01

Regulatory Status

RX

2020
01 Oct
RX Application: 207849

Drug Name

MIDODRINE HYDROCHLORIDE

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2020-10-01

207849 / 3

Active Ingredient

MIDODRINE HYDROCHLORIDE

Application Number

207849

Product Number

3

Dosage Form

-

Strength

10MG

Approval Date

2020-10-01

Regulatory Status

RX

2020
22 Sep
RX Application: 210038

Drug Name

NAFTIFINE HYDROCHLORIDE

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2020-09-22

210038 / 1

Active Ingredient

NAFTIFINE HYDROCHLORIDE

Application Number

210038

Product Number

1

Dosage Form

-

Strength

2%

Approval Date

2020-09-22

Regulatory Status

RX

2013
12 Jun
RX Application: 200980

Drug Name

NORETHINDRONE

Product Number

1

Dosage Form

-

Strength

0.35MG

Approval Date

2013-06-12

200980 / 1

Active Ingredient

NORETHINDRONE

Application Number

200980

Product Number

1

Dosage Form

-

Strength

0.35MG

Approval Date

2013-06-12

Regulatory Status

RX

2013
24 Jun
RX Application: 201483

Drug Name

NORETHINDRONE

Product Number

1

Dosage Form

-

Strength

0.35MG

Approval Date

2013-06-24

201483 / 1

Active Ingredient

NORETHINDRONE

Application Number

201483

Product Number

1

Dosage Form

-

Strength

0.35MG

Approval Date

2013-06-24

Regulatory Status

RX

2016
10 Nov
RX Application: 205278

Drug Name

NORETHINDRONE ACETATE

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2016-11-10

205278 / 1

Active Ingredient

NORETHINDRONE ACETATE

Application Number

205278

Product Number

1

Dosage Form

-

Strength

5MG

Approval Date

2016-11-10

Regulatory Status

RX

2015
20 Feb
RX Application: 202741

Drug Name

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.03MG;1.5MG

Approval Date

2015-02-20

202741 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

202741

Product Number

1

Dosage Form

-

Strength

0.03MG;1.5MG

Approval Date

2015-02-20

Regulatory Status

RX

2015
19 Feb
RX Application: 202770

Drug Name

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.03MG;1.5MG

Approval Date

2015-02-19

202770 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

202770

Product Number

1

Dosage Form

-

Strength

0.03MG;1.5MG

Approval Date

2015-02-19

Regulatory Status

RX

2013
06 Nov
RX Application: 202771

Drug Name

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG

Approval Date

2013-11-06

202771 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

202771

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG

Approval Date

2013-11-06

Regulatory Status

RX

2013
14 Nov
RX Application: 202772

Drug Name

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG

Approval Date

2013-11-14

202772 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

202772

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG

Approval Date

2013-11-14

Regulatory Status

RX

2018
22 Jun
RX Application: 205069

Drug Name

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.02MG,0.03MG,0.035MG;1MG,1MG,1MG

Approval Date

2018-06-22

205069 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

205069

Product Number

1

Dosage Form

-

Strength

0.02MG,0.03MG,0.035MG;1MG,1MG,1MG

Approval Date

2018-06-22

Regulatory Status

RX

2016
27 Dec
Discontinued Application: 207259

Drug Name

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.005MG;1MG

Approval Date

2016-12-27

207259 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

207259

Product Number

1

Dosage Form

-

Strength

0.005MG;1MG

Approval Date

2016-12-27

Regulatory Status

Discontinued

2017
02 Feb
Discontinued Application: 207260

Drug Name

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.0025MG;0.5MG

Approval Date

2017-02-02

207260 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

207260

Product Number

1

Dosage Form

-

Strength

0.0025MG;0.5MG

Approval Date

2017-02-02

Regulatory Status

Discontinued

2016
31 May
Discontinued Application: 205049

Drug Name

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Product Number

1

Dosage Form

-

Strength

0.01MG,0.01MG;1MG,N/A

Approval Date

2016-05-31

205049 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

205049

Product Number

1

Dosage Form

-

Strength

0.01MG,0.01MG;1MG,N/A

Approval Date

2016-05-31

Regulatory Status

Discontinued

2014
30 Oct
Discontinued Application: 202742

Drug Name

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG

Approval Date

2014-10-30

202742 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

202742

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG

Approval Date

2014-10-30

Regulatory Status

Discontinued

2017
12 Sep
Discontinued Application: 206120

Drug Name

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG

Approval Date

2017-09-12

206120 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

206120

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG

Approval Date

2017-09-12

Regulatory Status

Discontinued

2018
16 Jul
RX Application: 209609

Drug Name

NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG

Approval Date

2018-07-16

209609 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Application Number

209609

Product Number

1

Dosage Form

-

Strength

0.02MG;1MG

Approval Date

2018-07-16

Regulatory Status

RX

2015
11 May
Discontinued Application: 200897

Drug Name

NORETHINDRONE AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.035MG;0.4MG

Approval Date

2015-05-11

200897 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE

Application Number

200897

Product Number

1

Dosage Form

-

Strength

0.035MG;0.4MG

Approval Date

2015-05-11

Regulatory Status

Discontinued

2013
05 Aug
Discontinued Application: 203006

Drug Name

NORETHINDRONE AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.05MG;1MG

Approval Date

2013-08-05

203006 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE

Application Number

203006

Product Number

1

Dosage Form

-

Strength

0.05MG;1MG

Approval Date

2013-08-05

Regulatory Status

Discontinued

2015
01 Apr
RX Application: 202086

Drug Name

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Product Number

1

Dosage Form

-

Strength

0.035MG;0.4MG

Approval Date

2015-04-01

202086 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE

Application Number

202086

Product Number

1

Dosage Form

-

Strength

0.035MG;0.4MG

Approval Date

2015-04-01

Regulatory Status

RX

2014
23 Apr
RX Application: 203371

Drug Name

NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Product Number

1

Dosage Form

-

Strength

0.025MG;0.8MG

Approval Date

2014-04-23

203371 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORETHINDRONE

Application Number

203371

Product Number

1

Dosage Form

-

Strength

0.025MG;0.8MG

Approval Date

2014-04-23

Regulatory Status

RX

2016
27 Jan
Discontinued Application: 201897

Drug Name

NORGESTIMATE AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG

Approval Date

2016-01-27

201897 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORGESTIMATE

Application Number

201897

Product Number

1

Dosage Form

-

Strength

0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG

Approval Date

2016-01-27

Regulatory Status

Discontinued

2015
09 Sep
Discontinued Application: 202132

Drug Name

NORGESTIMATE AND ETHINYL ESTRADIOL

Product Number

1

Dosage Form

-

Strength

0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG

Approval Date

2015-09-09

202132 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORGESTIMATE

Application Number

202132

Product Number

1

Dosage Form

-

Strength

0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG

Approval Date

2015-09-09

Regulatory Status

Discontinued

2020
10 Dec
RX Application: 212977

Drug Name

OMEPRAZOLE

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2020-12-10

212977 / 1

Active Ingredient

OMEPRAZOLE

Application Number

212977

Product Number

1

Dosage Form

-

Strength

10MG

Approval Date

2020-12-10

Regulatory Status

RX

2020
10 Dec
RX Application: 212977

Drug Name

OMEPRAZOLE

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2020-12-10

212977 / 2

Active Ingredient

OMEPRAZOLE

Application Number

212977

Product Number

2

Dosage Form

-

Strength

20MG

Approval Date

2020-12-10

Regulatory Status

RX

2024
27 Dec
RX Application: 212977

Drug Name

OMEPRAZOLE

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2024-12-27

212977 / 3

Active Ingredient

OMEPRAZOLE

Application Number

212977

Product Number

3

Dosage Form

-

Strength

40MG

Approval Date

2024-12-27

Regulatory Status

RX

2017
20 Oct
RX Application: 205229

Drug Name

PROGESTERONE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2017-10-20

205229 / 1

Active Ingredient

PROGESTERONE

Application Number

205229

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2017-10-20

Regulatory Status

RX

2017
20 Oct
RX Application: 205229

Drug Name

PROGESTERONE

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2017-10-20

205229 / 2

Active Ingredient

PROGESTERONE

Application Number

205229

Product Number

2

Dosage Form

-

Strength

200MG

Approval Date

2017-10-20

Regulatory Status

RX

2022
05 Jan
RX Application: 215634

Drug Name

PROGESTERONE

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2022-01-05

215634 / 1

Active Ingredient

PROGESTERONE

Application Number

215634

Product Number

1

Dosage Form

-

Strength

50MG/ML

Approval Date

2022-01-05

Regulatory Status

RX

2025
19 Sep
RX Application: 218391

Drug Name

PROGESTERONE

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2025-09-19

218391 / 1

Active Ingredient

PROGESTERONE

Application Number

218391

Product Number

1

Dosage Form

-

Strength

100MG

Approval Date

2025-09-19

Regulatory Status

RX

2022
25 Nov
RX Application: 216209

Drug Name

RAMELTEON

Product Number

1

Dosage Form

-

Strength

8MG

Approval Date

2022-11-25

216209 / 1

Active Ingredient

RAMELTEON

Application Number

216209

Product Number

1

Dosage Form

-

Strength

8MG

Approval Date

2022-11-25

Regulatory Status

RX

2020
29 Oct
Discontinued Application: 211277

Drug Name

SODIUM NITROPRUSSIDE

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

2020-10-29

211277 / 1

Active Ingredient

SODIUM NITROPRUSSIDE

Application Number

211277

Product Number

1

Dosage Form

-

Strength

25MG/ML

Approval Date

2020-10-29

Regulatory Status

Discontinued

2011
28 Mar
RX Application: 90114

Drug Name

SYEDA

Product Number

1

Dosage Form

-

Strength

3MG;0.03MG

Approval Date

2011-03-28

90114 / 1

Active Ingredient

DROSPIRENONE; ETHINYL ESTRADIOL

Application Number

90114

Product Number

1

Dosage Form

-

Strength

3MG;0.03MG

Approval Date

2011-03-28

Regulatory Status

RX

2020
16 Apr
RX Application: 210835

Drug Name

TESTOSTERONE

Product Number

1

Dosage Form

-

Strength

1.62% (20.25MG/1.25GM ACTUATION)

Approval Date

2020-04-16

210835 / 1

Active Ingredient

TESTOSTERONE

Application Number

210835

Product Number

1

Dosage Form

-

Strength

1.62% (20.25MG/1.25GM ACTUATION)

Approval Date

2020-04-16

Regulatory Status

RX

2023
13 Apr
RX Application: 215351

Drug Name

TESTOSTERONE CYPIONATE

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2023-04-13

215351 / 1

Active Ingredient

TESTOSTERONE CYPIONATE

Application Number

215351

Product Number

1

Dosage Form

-

Strength

100MG/ML

Approval Date

2023-04-13

Regulatory Status

RX

2023
13 Apr
RX Application: 215351

Drug Name

TESTOSTERONE CYPIONATE

Product Number

2

Dosage Form

-

Strength

200MG/ML

Approval Date

2023-04-13

215351 / 2

Active Ingredient

TESTOSTERONE CYPIONATE

Application Number

215351

Product Number

2

Dosage Form

-

Strength

200MG/ML

Approval Date

2023-04-13

Regulatory Status

RX

2013
30 Jan
RX Application: 90793

Drug Name

TRI-ESTARYLLA

Product Number

1

Dosage Form

-

Strength

0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG

Approval Date

2013-01-30

90793 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORGESTIMATE

Application Number

90793

Product Number

1

Dosage Form

-

Strength

0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG

Approval Date

2013-01-30

Regulatory Status

RX

2015
29 Jun
RX Application: 91232

Drug Name

TRI-LO-ESTARYLLA

Product Number

1

Dosage Form

-

Strength

0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG

Approval Date

2015-06-29

91232 / 1

Active Ingredient

ETHINYL ESTRADIOL; NORGESTIMATE

Application Number

91232

Product Number

1

Dosage Form

-

Strength

0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG

Approval Date

2015-06-29

Regulatory Status

RX

2015
21 May
RX Application: 201088

Drug Name

VIENVA

Product Number

1

Dosage Form

-

Strength

0.02MG;0.1MG

Approval Date

2015-05-21

201088 / 1

Active Ingredient

ETHINYL ESTRADIOL; LEVONORGESTREL

Application Number

201088

Product Number

1

Dosage Form

-

Strength

0.02MG;0.1MG

Approval Date

2015-05-21

Regulatory Status

RX

2016
09 Sep
RX Application: 202689

Drug Name

VOLNEA

Product Number

1

Dosage Form

-

Strength

0.15MG,N/A;0.02MG,0.01MG

Approval Date

2016-09-09

202689 / 1

Active Ingredient

DESOGESTREL; ETHINYL ESTRADIOL

Application Number

202689

Product Number

1

Dosage Form

-

Strength

0.15MG,N/A;0.02MG,0.01MG

Approval Date

2016-09-09

Regulatory Status

RX

Related Databases
  • FDA Inspections
    0 View
  • EDQM CEP
    0 View
  • KDMF
    0 View
  • Japan DMF
    0 View
  • Eudra GMP
    0 View
  • NDC Database
    0 View
  • FDA Approved Drugs Database
    99 View
  • Drug Prices in Switzerland
    0 View
Drug Status Breakdown
99 total
  • RX
  • Discontinued
  • 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

ACYCLOVIR

Application Number

201501

Product Number

1

Active Ingredient

ACYCLOVIR

Dosage Form

-

Strength

5%

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

Create a New Buying Request

Fields marked with * are mandatory.

Please enter quantity.
Please select a unit.
Please select quality standard.
Please select request type.
Please provide product specifications.
Please enter additional details.
Please select shipping preference.
Notice: By submitting this buying request, the provided product details and requirements may be published publicly on our marketplace.
Login to Submit