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Approved Drug Products containing 19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17alpha) listed in the FDA Orange Book. Original Data : FDA Website

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01 2ABBVIE ENDOCRINE

02 6DR REDDYS LABS SA

03 2BRECKENRIDGE PHARM

04 2AMNEAL

05 4AMNEAL PHARMS

06 8APIL

07 1APOTEX

08 6AUROBINDO PHARMA

09 3AUROBINDO PHARMA LTD

10 8BARR

11 2BARR LABS INC

12 1DURAMED RES

13 5ENDO OPERATIONS

14 9GLENMARK PHARMS LTD

15 2GLENMARK SPECLT

16 1LUPIN

17 8LUPIN LTD

18 1MILLICENT PR

19 1NAARI PTE LTD

20 11NOVAST LABS

21 1NOVAST LABS LTD

22 2NOVEN PHARMS INC

23 1NOVO NORDISK

24 1NOVO NORDISK INC

25 6PARKE DAVIS

26 1SUMITOMO PHARMA

27 5TEVA BRANDED PHARM

28 1TEVA PHARMS USA

29 1TEVA PHARMS USA INC

30 1WARNER CHILCOTT

31 1WILSHIRE PHARMS INC

32 15XIROMED

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PharmaCompass

01

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AAPS 2024
Not Confirmed

LEUPROLIDE ACETATE; NORETHINDRONE ACETATE

Brand Name : LUPANETA PACK

Dosage Form : INJECTABLE, TABLET;INTRAMUSCULAR, ORAL

Dosage Strength : 3.75MG/VIAL,N/A;N/A,5MG

Approval Date : 2012-12-14

Application Number : 203696

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Abbvie Company Banner

02

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code :

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Brand Name : MICROGESTIN FE 1.5/30

Dosage Form : TABLET;ORAL-28

Dosage Strength : 0.03MG;1.5MG

Approval Date : 2001-02-05

Application Number : 75548

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Dr Reddy Company Banner

03

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AAPS 2024
Not Confirmed

ESTRADIOL; NORETHINDRONE ACETATE

Brand Name : ESTRADIOL AND NORETHINDRONE ACETATE

Dosage Form : TABLET;ORAL

Dosage Strength : 1MG;0.5MG

Approval Date : 2008-04-17

Application Number : 78324

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Breckenridge Pharmaceutical

04

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AAPS 2024
Not Confirmed

LEUPROLIDE ACETATE; NORETHINDRONE ACETATE

Brand Name : LUPANETA PACK

Dosage Form : INJECTABLE, TABLET;INTRAMUSCULAR, ORAL

Dosage Strength : 11.25MG/VIAL,N/A;N/A,5MG

Approval Date : 2012-12-14

Application Number : 203696

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Abbvie Company Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code :

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Brand Name : MICROGESTIN 1.5/30

Dosage Form : TABLET;ORAL-21

Dosage Strength : 0.03MG;1.5MG

Approval Date : 2003-07-30

Application Number : 75548

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Dr Reddy Company Banner

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code :

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Brand Name : MICROGESTIN FE 1/20

Dosage Form : TABLET;ORAL-28

Dosage Strength : 0.02MG;1MG

Approval Date : 2001-02-05

Application Number : 75647

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Dr Reddy Company Banner

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code :

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Brand Name : MICROGESTIN 1/20

Dosage Form : TABLET;ORAL-21

Dosage Strength : 0.02MG;1MG

Approval Date : 2003-07-30

Application Number : 75647

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Dr Reddy Company Banner

08

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code :

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Brand Name : NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL

Dosage Form : TABLET;ORAL-28

Dosage Strength : 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG

Approval Date : 2010-03-18

Application Number : 76629

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Dr Reddy Company Banner

09

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothDRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.

RLD : No

TE Code :

ETHINYL ESTRADIOL; NORETHINDRONE ACETATE

Brand Name : NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE

Dosage Form : CAPSULE;ORAL

Dosage Strength : 0.02MG;1MG

Approval Date : 2022-04-28

Application Number : 213901

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

Dr Reddy Company Banner

10

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AAPS 2024
Not Confirmed

ESTRADIOL; NORETHINDRONE ACETATE

Brand Name : ESTRADIOL AND NORETHINDRONE ACETATE

Dosage Form : TABLET;ORAL

Dosage Strength : 0.5MG;0.1MG

Approval Date : 2011-06-09

Application Number : 78324

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Breckenridge Pharmaceutical