(-)-Norgestrel | 21225 | SYSTEM;INTRAUTERINE | 52MG

(+-)-Norgestrel

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ACTIVE PHARMA INGREDIENTS

44 API Suppliers, 28 USDMF, 11 CEP/COS, 4 JDMF, 5 EU WC, 19 NDC API, 15 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

22 Drugs in Development

22 Drugs in Development

INTERMEDIATES

4 Intermediates Suppliers

4 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

295 FDF Dossiers, 136 FDA Orange Book, 80 Europe, 30 Canada, 3 Australia, 27 South Africa, 19 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL-28 - 0.03MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A, SYSTEM;INTRAUTERINE - 52MG, TABLET;ORAL - 0.02MG;0.1MG, SYSTEM;INTRAUTERINE - 52MG, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.045MG/24HR;0.015MG/24HR, TABLET;ORAL - 1.5MG

RELATED EXCIPIENT COMPANIES

5 SPI Pharma, 2 Seqens, 7 DKSH, 5 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 12 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 17 BASF, 11 Corel Pharma Chem, 5 DFE Pharma, 1 Doshion Polyscience, 1 Finar, 7 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 29 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 2 Nomisma Healthcare, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 17 Roquette, 7 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 11 Sigachi Industries, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

70 Fillers, Diluents & Binders, 44 Coating Systems & Additives, 31 Direct Compression, 28 Controlled & Modified Release, 24 Disintegrants & Superdisintegrants, 22 Thickeners and Stabilizers, 20 Granulation, 16 Co-Processed Excipients, 14 Lubricants & Glidants, 13 Solubilizers, 10 Taste Masking, 9 Empty Capsules, 8 Film Formers & Plasticizers, 7 Topical, 6 Chewable & Orodispersible Aids, 5 API Stability Enhancers, 5 Parenteral, 4 Coloring Agents, 4 Emulsifying Agents, 4 Vegetarian Capsules, 3 Rheology Modifiers

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USFDA APPLICATION NUMBER - 21225 / DOSAGE - SYSTEM;INTRAUTERINE - 52MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVONORGESTREL(UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW)	LEVONORGESTREL	52mg

Inactive Ingredients

Ingredient Name	Actavis Pharma, Inc.	Bayer HealthCare Pharmaceuticals Inc.
BARIUM SULFATE(25BB7EKE2E)
DIMETHICONE(92RU3N3Y1O)

Drug Product Composition: (-)-Norgestrel

(+-)-Norgestrel

(+-)-Norgestrel

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

44 API Suppliers

28 USDMF

11 CEP/COS

4 JDMF

5 EU WC

19 NDC API

15 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

22 Drugs in Development

INTERMEDIATES

4 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

295 FDF Dossiers

136 FDA Orange Book

80 Europe

30 Canada

3 Australia

27 South Africa

19 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL-28 - 0.03MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A

SYSTEM;INTRAUTERINE - 52MG

TABLET;ORAL - 0.02MG;0.1MG

SYSTEM;INTRAUTERINE - 52MG

FILM, EXTENDED RELEASE;TRANSDERMAL - 0.045MG/24HR;0.015MG/24HR

TABLET;ORAL - 1.5MG

RELATED EXCIPIENT COMPANIES

5 SPI Pharma

2 Seqens

7 DKSH

5 Faran Shimi Pharmaceutical

4 Boai NKY Pharmaceuticals Ltd

12 Gangwal Healthcare

1 Nanjing Well Pharmaceutical

4 ACG Worldwide

3 Actylis

1 Aeon Procare

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

17 BASF

11 Corel Pharma Chem

5 DFE Pharma

1 Doshion Polyscience

1 Finar

7 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

3 Ingredion Pharma Solutions

29 Kerry

3 Kima Chemical

6 Lonza Capsugel

11 Microlex e.U

2 Nomisma Healthcare

2 Novo Excipients

2 Pharmatrans-Sanaq

5 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

17 Roquette

7 Seppic

7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

11 Sigachi Industries

2 The Dow Chemical Company

1 Ulanqab Kema New Material

1 Valens Pharmachem

3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

70 Fillers, Diluents & Binders

44 Coating Systems & Additives

31 Direct Compression

TABLET;ORAL-28 - 0.03MG;0.3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons