Mayne Pharma RX
FDA Approved Drugs

Mayne Pharma 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 13
  • Latest Approval Date Apr 22, 2022
  • Data Source FDA
  • First Approval Date Oct 06, 2010
All
27
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Discontinued
14
View
RX
13
View
Company Overview

Company

Mayne Pharma RX

Country

Australia

Website

Visit Website

Email

bd@maynepharma.com

Social Profiles

Company Snapshot

Mayne Pharma RX

1538 Main North Road, Salisbury South, SA 5106

Australia

www.maynepharma.com/ bd@maynepharma.com View on Map
FDA Approved Drug Records ( 13 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

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

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

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

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
13 total
  • RX
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

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

Regular Updates

Data maintained from official sources

Structured Database

Searchable pharmaceutical data

Reliable Data

Organized FDA drug records

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