Norethisterone

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ACTIVE PHARMA INGREDIENTS

32 API Suppliers, 15 USDMF, 8 CEP/COS, 4 JDMF, 5 EU WC, 7 NDC API, 13 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

180 FDF Dossiers, 116 FDA Orange Book, 20 Europe, 13 Canada, 3 Australia, 17 South Africa, 11 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL-28 - 0.05MG;1MG, TABLET;ORAL-28 - 0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.35MG, TABLET;ORAL-28 - 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, CHEWABLE;ORAL - 0.025MG;0.8MG

RELATED EXCIPIENT COMPANIES

4 SPI Pharma, 4 DKSH, 4 Faran Shimi Pharmaceutical, 8 Boai NKY Pharmaceuticals Ltd, 12 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 1 Aeon Procare, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 12 BASF, 11 Corel Pharma Chem, 6 DFE Pharma, 7 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 5 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 36 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 13 Microlex e.U, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 4 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 17 Roquette, 7 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 11 Sigachi Industries, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

81 Fillers, Diluents & Binders, 46 Coating Systems & Additives, 35 Direct Compression, 27 Controlled & Modified Release, 22 Granulation, 20 Disintegrants & Superdisintegrants, 19 Co-Processed Excipients, 17 Thickeners and Stabilizers, 16 Lubricants & Glidants, 16 Film Formers & Plasticizers, 10 Taste Masking, 10 Solubilizers, 6 Chewable & Orodispersible Aids, 5 Empty Capsules, 5 API Stability Enhancers, 4 Emulsifying Agents, 4 Vegetarian Capsules, 4 Coloring Agents, 3 Parenteral, 2 Rheology Modifiers

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10 US Medicaid Prescriptions, 29 Finished Drug Prices, 1 Annual Reports

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7 APIs, 1 FDF Dossiers

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USFDA APPLICATION NUMBER - 16954 / DOSAGE - TABLET;ORAL-28 - 0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NORETHINDRONE(UNII: T18F433X4S) (NORETHINDRONE - UNII:T18F433X4S)	NORETHINDRONE	0.35mg

Inactive Ingredients

Ingredient Name	Actavis Pharma, Inc.	Janssen Pharmaceuticals, Inc.
D&C GREEN No. 5(8J6RDU8L9X)
D&C YELLOW No. 10(35SW5USQ3G)
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)
MAGNESIUM STEARATE(70097M6I30)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)(461P5CJN6T)
POVIDONE, UNSPECIFIED(FZ989GH94E)

Drug Product Composition: Norethisterone

Norethisterone

Norethisterone

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ACTIVE PHARMA INGREDIENTS

32 API Suppliers

15 USDMF

8 CEP/COS

4 JDMF

5 EU WC

7 NDC API

13 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

INTERMEDIATES

1 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

180 FDF Dossiers

116 FDA Orange Book

20 Europe

13 Canada

3 Australia

17 South Africa

11 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL-28 - 0.05MG;1MG

TABLET;ORAL-28 - 0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL-28 - 0.35MG

TABLET;ORAL-28 - 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG

TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, CHEWABLE;ORAL - 0.025MG;0.8MG

RELATED EXCIPIENT COMPANIES

4 SPI Pharma

4 DKSH

4 Faran Shimi Pharmaceutical

8 Boai NKY Pharmaceuticals Ltd

12 Gangwal Healthcare

1 Nanjing Well Pharmaceutical

1 ACG Worldwide

1 Aeon Procare

1 Alcedo Pharmachem

6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

12 BASF

11 Corel Pharma Chem

6 DFE Pharma

7 Gangwal Chemicals

1 Huzhou Sunflower Pharmaceutical

5 Ideal Cures Pvt Ltd

3 Ingredion Pharma Solutions

36 Kerry

4 Kima Chemical

6 Lonza Capsugel

13 Microlex e.U

3 Novo Excipients

3 Pharmatrans-Sanaq

4 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

17 Roquette

7 Seppic

5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

11 Sigachi Industries

3 The Dow Chemical Company

2 Ulanqab Kema New Material

3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

81 Fillers, Diluents & Binders

46 Coating Systems & Additives

35 Direct Compression

27 Controlled & Modified Release

22 Granulation

20 Disintegrants & Superdisintegrants

TABLET;ORAL-28 - 0.35MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL-28 - 0.035MG;1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 0.035MG;0.4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons