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19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17alpha)

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ACTIVE PHARMA INGREDIENTS

22 API Suppliers, 12 USDMF, 4 CEP/COS, 2 JDMF, 3 EU WC, 6 NDC API, 12 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

25 Drugs in Development

25 Drugs in Development

FINISHED DOSAGE FORMULATIONS

168 FDF Dossiers, 119 FDA Orange Book, 39 Europe, 7 Canada, 3 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL-28 - 0.02MG;1MG, TABLET;ORAL-21 - 0.03MG;1.5MG, TABLET;ORAL-21 - 0.03MG;1.5MG, TABLET;ORAL-21 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 3.75MG/VIAL,N/A;N/A,5MG, CAPSULE;ORAL - 0.02MG;1MG, TABLET, CHEWABLE, TABLET;ORAL - 0.01MG,0.01MG,N/A;1MG,N/A,N/A, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.14MG/24HR, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.25MG/24HR, TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1MG;0.5MG, TABLET;ORAL - 0.0025MG;0.5MG, TABLET;ORAL - 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.01MG,0.01MG;1MG,N/A

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 5 SPI Pharma, 4 DKSH, 2 Jai Radhe Sales, 6 Boai NKY Pharmaceuticals Ltd, 13 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 4 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 19 BASF, 2 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 11 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 7 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 38 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 15 Microlex e.U, 1 Nanjing Bold Chemical, 4 Novo Excipients, 3 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 23 Roquette, 13 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 12 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 5 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

85 Fillers, Diluents & Binders, 56 Coating Systems & Additives, 41 Direct Compression, 34 Disintegrants & Superdisintegrants, 29 Controlled & Modified Release, 27 Granulation, 26 Solubilizers, 23 Thickeners and Stabilizers, 21 Lubricants & Glidants, 19 Co-Processed Excipients, 17 Taste Masking, 16 Film Formers & Plasticizers, 14 Parenteral, 10 Emulsifying Agents, 9 Topical, 8 API Stability Enhancers, 7 Chewable & Orodispersible Aids, 6 Rheology Modifiers, 5 Empty Capsules, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

3 DATA COMPILATION #PharmaFlow, 47 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

2 US Medicaid Prescriptions, 40 Finished Drug Prices, 9 Annual Reports

MARKET PLACE

7 APIs

7 APIs

PATENTS & EXCLUSIVITIES

9 US Patents, 4 US Exclusivities

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 3 Others

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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
26/09/2024	Sanofi	France	ROUSSEL CORP	1846	NORETHINDRONE ACETATE	1971-12-22	Inactive	II	N/A
26/09/2024	Aspen API	Netherlands	ASPEN OSS BV	10185	NORETHINDRONE ACETATE	1993-04-12	Active	II	Complete	2012-12-26	2012-11-14

List of Drug Master Files (DMF) of 19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17alpha) Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17alpha)

19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17alpha)

ACCESS ALL DATA

Browse all information

CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

22 API Suppliers

12 USDMF

4 CEP/COS

2 JDMF

3 EU WC

6 NDC API

12 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

25 Drugs in Development

PRICE INFORMATION

API Reference Price

API Exports

API Imports

FDF Imports

FINISHED DOSAGE FORMULATIONS

168 FDF Dossiers

119 FDA Orange Book

39 Europe

7 Canada

3 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL-28 - 0.02MG;1MG

TABLET;ORAL-21 - 0.03MG;1.5MG

TABLET;ORAL-21 - 0.03MG;1.5MG

TABLET;ORAL-21 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL-21 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG

INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 3.75MG/VIAL,N/A;N/A,5MG

CAPSULE;ORAL - 0.02MG;1MG

TABLET, CHEWABLE, TABLET;ORAL - 0.01MG,0.01MG,N/A;1MG,N/A,N/A

FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.14MG/24HR

FILM, EXTENDED RELEASE;TRANSDERMAL - 0.05MG/24HR;0.25MG/24HR

TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 1MG;0.5MG

TABLET;ORAL - 0.0025MG;0.5MG

TABLET;ORAL - 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 0.01MG,0.01MG;1MG,N/A

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc

5 SPI Pharma

4 DKSH

2 Jai Radhe Sales

6 Boai NKY Pharmaceuticals Ltd

13 Gangwal Healthcare

6 Nanjing Well Pharmaceutical

1 Pfanstiehl

1 ACG Worldwide

4 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

9 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

19 BASF

2 Clariant

11 Corel Pharma Chem

7 DFE Pharma

1 Doshion Polyscience

11 Gangwal Chemicals

1 Huzhou Sunflower Pharmaceutical

7 Ideal Cures Pvt Ltd

4 Ingredion Pharma Solutions

38 Kerry

3 Kima Chemical

6 Lonza Capsugel

15 Microlex e.U

1 Nanjing Bold Chemical

4 Novo Excipients

3 Pharmatrans-Sanaq

7 Pluviaendo

4 Prachin Chemical

TABLET;ORAL-21 - 0.02MG;1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL-21 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 0.02MG;1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 0.5MG;0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 0.005MG;1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 0.02MG;1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons