(-)-13-Ethyl-17-hydroxy-18,19-dinor-17alpha-pregn-4-en-20-yn-3-one

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ACTIVE PHARMA INGREDIENTS

57 API Suppliers, 30 USDMF, 12 CEP/COS, 3 JDMF, 8 EU WC, 22 NDC API, 18 Listed Suppliers

DEVELOPMENTS

66 Drugs in Development

66 Drugs in Development

INTERMEDIATES

4 Intermediate Suppliers

4 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

527 FDF Dossiers, 137 FDA Orange Book, 289 Europe, 31 Canada, 16 Australia, 32 South Africa, 22 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TABLET;ORAL-28 - 0.03MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A, SYSTEM;INTRAUTERINE - 52MG, TABLET;ORAL -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, 4 Boai NKY Pharmaceuticals Ltd, 4 Gangwal Healthcare, 1 Nanjing Well Pharmaceutical, 1 Cerata Pharmaceuticals LLP, 1 Dr. Paul Lohmann GmbH & Co. KGaA, 4 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 17 BASF, 11 Corel Pharma Chem, 5 DFE Pharma, 1 Doshion Polyscience, 1 Esteem Industries, 1 Finar, 7 Gangwal Chemicals, 4 Ideal Cures, 3 Ingredion Pharma Solutions, 19 Kerry, 2 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 11 Microlex e.U, 1 Neelkanth MineChem, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Pharmachem, 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, 10 Sigachi Industries, 3 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

53 Fillers, Diluents & Binders, 38 Coating Systems & Additives, 23 Direct Compression, 23 Granulation, 22 Controlled & Modified Release, 21 Disintegrants & Superdisintegrants, 17 Thickeners and Stabilizers, 14 Solubilizers, 13 Lubricants & Glidants, 13 Co-Processed Excipients, 10 Taste Masking, 9 Empty Capsules, 8 Topical, 7 Chewable & Orodispersible Aids, 7 Film Formers & Plasticizers, 5 API Stability Enhancers, 4 Emulsifying Agents, 4 Vegetarian Capsules, 3 Rheology Modifiers, 3 Parenteral, 2 Coloring Agents

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GLOBAL SALES INFORMATION

45 US Medicaid Prescriptions, 15 Regulatory FDF Prices, 15 Annual Reports

MARKET PLACE

9 APIs, 6 FDF Dossiers

PATENTS & EXCLUSIVITIES

19 US Patents, 2 US Exclusivities

REF. STANDARDS & IMPURITIES

5 EDQM, 1 JP, 11 Others

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USFDA APPLICATION NUMBER - 21998 / DOSAGE - TABLET;ORAL - 1.5MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LEVONORGESTREL(UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW)	LEVONORGESTREL	1.5mg

Inactive Ingredients

Ingredient Name	Actavis Pharma, Inc.	NuCare Pharmaceuticals,Inc.	Bionpharma Inc.	A-S Medication Solutions	Afaxys Pharma, LLC	Combe Incorporated	Glenmark Pharmaceuticals Inc., USA	Lotus Pharmaceutical Co., Ltd. Nantou Plant	Lupin Pharmaceuticals, Inc.	Northstar Rx LLC	Syzygy Healthcare Solutions, LLC PO Box 588, Westport, CT 06880	Teva Women's Health, Inc.
FD&C YELLOW NO. 6(H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
POVIDONE K25(K0KQV10C35)
POVIDONE K30(U725QWY32X)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
SILICON DIOXIDE(ETJ7Z6XBU4)
STARCH, CORN(O8232NY3SJ)
STARCH, POTATO(8I089SAH3T)
STARCH, PREGELATINIZED CORN(O8232NY3SJ)
TALC(7SEV7J4R1U)

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Setid 98f46182 3656 4381 8e2a 88f7fb48c0de Applno 21998 Form Tablet Oral Dosage 1 5mg - Drug Product Composition: (-)-13-Ethyl-17-hydroxy-18,19-dinor-17alpha-pregn-4-en-20-yn-3-one