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

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ACTIVE PHARMA INGREDIENTS

21 API Suppliers, 12 USDMF, 4 CEP/COS, 2 JDMF, 3 EU WC, 6 NDC API, 11 Listed Suppliers, $ API Reference Price

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25 Drugs in Development

25 Drugs in Development

FINISHED DOSAGE FORMULATIONS

171 FDF Dossiers, 119 FDA Orange Book, 39 Europe, 7 Canada, 6 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- 0.03MG;1.5MG, TABLET;ORAL-21 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL -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TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1MG;0.5MG, TABLET;ORAL - 0.0025MG;0.5MG, TABLET;ORAL - 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.01MG,0.01MG;1MG,N/A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, 7 Faran Shimi Pharmaceutical, 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

86 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

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

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PATENTS & EXCLUSIVITIES

9 US Patents, 5 US Exclusivities

REF. STANDARDS & IMPURITIES

2 EDQM, 1 USP, 3 Others

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USFDA APPLICATION NUMBER - 21065 / DOSAGE - TABLET;ORAL - 0.0025MG;0.5MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ETHINYL ESTRADIOL(UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)	ETHINYL ESTRADIOL	2.5ug
NORETHINDRONE ACETATE(UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S)	NORETHINDRONE ACETATE	0.5mg

Inactive Ingredients

Ingredient Name	Actavis Pharma, Inc.	Allergan, Inc.	Lupin Pharmaceuticals, Inc.
CALCIUM STEARATE(776XM7047L)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
FD&C BLUE NO. 2(L06K8R7DQK)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
POLYETHYLENE GLYCOL 400(B697894SGQ)
STARCH, CORN(O8232NY3SJ)
TITANIUM DIOXIDE(15FIX9V2JP)
TOCOPHEROL(R0ZB2556P8)

Drug Product Composition: 19-Norpregn-4-en-20-yn-3-one, 17-(acetyloxy)-, (17alpha)