Mayne Pharma
FDA Approved Drugs

Mayne 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
  • Total Records 27
  • Latest Approval Date Apr 22, 2022
  • Data Source FDA
  • First Approval Date Jul 22, 1985
All
27
View
Discontinued
14
View
RX
13
View
Company Overview

Company

Mayne Pharma

Country

Australia

Website

Visit Website

Email

bd@maynepharma.com

Social Profiles

Company Snapshot

Mayne Pharma

1538 Main North Road, Salisbury South, SA 5106

Australia

www.maynepharma.com/ bd@maynepharma.com View on Map
FDA Approved Drug Records ( 27 records )
2018
10 Aug
RX Application: 209627

Drug Name

ANNOVERA

Product Number

1

Dosage Form

-

Strength

0.013MG/24HR;0.15MG/24HR

Approval Date

2018-08-10

209627 / 1

Active Ingredient

ETHINYL ESTRADIOL; SEGESTERONE ACETATE

Application Number

209627

Product Number

1

Dosage Form

-

Strength

0.013MG/24HR;0.15MG/24HR

Approval Date

2018-08-10

Regulatory Status

RX

2018
28 Oct
RX Application: 210132

Drug Name

BIJUVA

Product Number

1

Dosage Form

-

Strength

1MG;100MG

Approval Date

2018-10-28

210132 / 1

Active Ingredient

ESTRADIOL; PROGESTERONE

Application Number

210132

Product Number

1

Dosage Form

-

Strength

1MG;100MG

Approval Date

2018-10-28

Regulatory Status

RX

2021
28 Dec
RX Application: 210132

Drug Name

BIJUVA

Product Number

2

Dosage Form

-

Strength

0.5MG;100MG

Approval Date

2021-12-28

210132 / 2

Active Ingredient

ESTRADIOL; PROGESTERONE

Application Number

210132

Product Number

2

Dosage Form

-

Strength

0.5MG;100MG

Approval Date

2021-12-28

Regulatory Status

RX

1985
22 Jul
Discontinued Application: 50582

Drug Name

DORYX

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1985-07-22

50582 / 1

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

50582

Product Number

1

Dosage Form

-

Strength

EQ 100MG BASE

Approval Date

1985-07-22

Regulatory Status

Discontinued

2001
13 Aug
Discontinued Application: 50582

Drug Name

DORYX

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2001-08-13

50582 / 2

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

50582

Product Number

2

Dosage Form

-

Strength

EQ 75MG BASE

Approval Date

2001-08-13

Regulatory Status

Discontinued

2005
06 May
Discontinued Application: 50795

Drug Name

DORYX

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2005-05-06

50795 / 1

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

50795

Product Number

1

Dosage Form

-

Strength

EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2005-05-06

Regulatory Status

Discontinued

2005
06 May
Discontinued Application: 50795

Drug Name

DORYX

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2005-05-06

50795 / 2

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

50795

Product Number

2

Dosage Form

-

Strength

EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2005-05-06

Regulatory Status

Discontinued

2008
20 Jun
Discontinued Application: 50795

Drug Name

DORYX

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2008-06-20

50795 / 3

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

50795

Product Number

3

Dosage Form

-

Strength

EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2008-06-20

Regulatory Status

Discontinued

2013
11 Apr
Discontinued Application: 50795

Drug Name

DORYX

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2013-04-11

50795 / 4

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

50795

Product Number

4

Dosage Form

-

Strength

EQ 80MG BASE

Approval Date

2013-04-11

Regulatory Status

Discontinued

2013
11 Apr
Discontinued Application: 50795

Drug Name

DORYX

Product Number

5

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2013-04-11

50795 / 5

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

50795

Product Number

5

Dosage Form

-

Strength

EQ 200MG BASE

Approval Date

2013-04-11

Regulatory Status

Discontinued

2014
19 Dec
Discontinued Application: 50795

Drug Name

DORYX

Product Number

6

Dosage Form

-

Strength

EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2014-12-19

50795 / 6

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

50795

Product Number

6

Dosage Form

-

Strength

EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2014-12-19

Regulatory Status

Discontinued

2016
20 May
RX Application: 50795

Drug Name

DORYX MPC

Product Number

7

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2016-05-20

50795 / 7

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

50795

Product Number

7

Dosage Form

-

Strength

EQ 60MG BASE

Approval Date

2016-05-20

Regulatory Status

RX

2016
20 May
Discontinued Application: 50795

Drug Name

DORYX MPC

Product Number

8

Dosage Form

-

Strength

EQ 120MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2016-05-20

50795 / 8

Active Ingredient

DOXYCYCLINE HYCLATE

Application Number

50795

Product Number

8

Dosage Form

-

Strength

EQ 120MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date

2016-05-20

Regulatory Status

Discontinued

2022
22 Apr
RX Application: 214510

Drug Name

EPSOLAY

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2022-04-22

214510 / 1

Active Ingredient

BENZOYL PEROXIDE

Application Number

214510

Product Number

1

Dosage Form

-

Strength

5%

Approval Date

2022-04-22

Regulatory Status

RX

2012
11 May
RX Application: 202428

Drug Name

FABIOR

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2012-05-11

202428 / 1

Active Ingredient

TAZAROTENE

Application Number

202428

Product Number

1

Dosage Form

-

Strength

0.1%

Approval Date

2012-05-11

Regulatory Status

RX

2007
20 Aug
Discontinued Application: 77062

Drug Name

FENTANYL-100

Product Number

4

Dosage Form

-

Strength

100MCG/HR

Approval Date

2007-08-20

77062 / 4

Active Ingredient

FENTANYL

Application Number

77062

Product Number

4

Dosage Form

-

Strength

100MCG/HR

Approval Date

2007-08-20

Regulatory Status

Discontinued

2007
20 Aug
Discontinued Application: 77062

Drug Name

FENTANYL-25

Product Number

1

Dosage Form

-

Strength

25MCG/HR

Approval Date

2007-08-20

77062 / 1

Active Ingredient

FENTANYL

Application Number

77062

Product Number

1

Dosage Form

-

Strength

25MCG/HR

Approval Date

2007-08-20

Regulatory Status

Discontinued

2007
20 Aug
Discontinued Application: 77062

Drug Name

FENTANYL-50

Product Number

2

Dosage Form

-

Strength

50MCG/HR

Approval Date

2007-08-20

77062 / 2

Active Ingredient

FENTANYL

Application Number

77062

Product Number

2

Dosage Form

-

Strength

50MCG/HR

Approval Date

2007-08-20

Regulatory Status

Discontinued

2007
20 Aug
Discontinued Application: 77062

Drug Name

FENTANYL-75

Product Number

3

Dosage Form

-

Strength

75MCG/HR

Approval Date

2007-08-20

77062 / 3

Active Ingredient

FENTANYL

Application Number

77062

Product Number

3

Dosage Form

-

Strength

75MCG/HR

Approval Date

2007-08-20

Regulatory Status

Discontinued

2018
29 May
RX Application: 208564

Drug Name

IMVEXXY

Product Number

1

Dosage Form

-

Strength

0.004MG

Approval Date

2018-05-29

208564 / 1

Active Ingredient

ESTRADIOL

Application Number

208564

Product Number

1

Dosage Form

-

Strength

0.004MG

Approval Date

2018-05-29

Regulatory Status

RX

2018
29 May
RX Application: 208564

Drug Name

IMVEXXY

Product Number

2

Dosage Form

-

Strength

0.01MG

Approval Date

2018-05-29

208564 / 2

Active Ingredient

ESTRADIOL

Application Number

208564

Product Number

2

Dosage Form

-

Strength

0.01MG

Approval Date

2018-05-29

Regulatory Status

RX

2018
24 May
Discontinued Application: 210566

Drug Name

LEXETTE

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2018-05-24

210566 / 1

Active Ingredient

HALOBETASOL PROPIONATE

Application Number

210566

Product Number

1

Dosage Form

-

Strength

0.05%

Approval Date

2018-05-24

Regulatory Status

Discontinued

2021
15 Apr
RX Application: 214154

Drug Name

NEXTSTELLIS

Product Number

1

Dosage Form

-

Strength

3MG;14.2MG

Approval Date

2021-04-15

214154 / 1

Active Ingredient

DROSPIRENONE; ESTETROL

Application Number

214154

Product Number

1

Dosage Form

-

Strength

3MG;14.2MG

Approval Date

2021-04-15

Regulatory Status

RX

2017
18 Jan
RX Application: 208552

Drug Name

RHOFADE

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2017-01-18

208552 / 1

Active Ingredient

OXYMETAZOLINE HYDROCHLORIDE

Application Number

208552

Product Number

1

Dosage Form

-

Strength

1%

Approval Date

2017-01-18

Regulatory Status

RX

2010
06 Oct
RX Application: 22563

Drug Name

SORILUX

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

2010-10-06

22563 / 1

Active Ingredient

CALCIPOTRIENE

Application Number

22563

Product Number

1

Dosage Form

-

Strength

0.005%

Approval Date

2010-10-06

Regulatory Status

RX

2018
11 Dec
RX Application: 208901

Drug Name

TOLSURA

Product Number

1

Dosage Form

-

Strength

65MG

Approval Date

2018-12-11

208901 / 1

Active Ingredient

ITRACONAZOLE

Application Number

208901

Product Number

1

Dosage Form

-

Strength

65MG

Approval Date

2018-12-11

Regulatory Status

RX

2021
26 Jul
RX Application: 214902

Drug Name

TWYNEO

Product Number

1

Dosage Form

-

Strength

3%;0.1%

Approval Date

2021-07-26

214902 / 1

Active Ingredient

BENZOYL PEROXIDE; TRETINOIN

Application Number

214902

Product Number

1

Dosage Form

-

Strength

3%;0.1%

Approval Date

2021-07-26

Regulatory Status

RX

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Drug Status Breakdown
27 total
  • RX
  • Discontinued
Official Source

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

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

Drug Name

ANNOVERA

Application Number

209627

Product Number

1

Active Ingredient

ETHINYL ESTRADIOL; SEGESTERONE ACETATE

Dosage Form

-

Strength

0.013MG/24HR;0.15MG/24HR

FDA Approved Drug Data

Approved drug product information

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Data maintained from official sources

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