17.alpha.-Ethynyl-19-nortestosterone

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ACTIVE PHARMA INGREDIENTS

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1 Drugs in Development

INTERMEDIATES

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- 0.05MG;1MG, TABLET;ORAL-28 - 0.35MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.35MG, TABLET;ORAL-28 - 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, CHEWABLE;ORAL - 0.025MG;0.8MG

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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, 7 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, 3 Ulanqab Kema New Material, 3 Vasa Pharmachem

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REF. STANDARDS & IMPURITIES

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USFDA APPLICATION NUMBER - 17060 / DOSAGE - TABLET;ORAL-28 - 0.35MG

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

Inactive Ingredients

Ingredient Name	A-S Medication Solutions	Lupin Pharmaceuticals, Inc.	Mayne Pharma Inc.	RPK Pharmaceuticals, Inc.	Teva Pharmaceuticals USA, Inc.	Afaxys Pharma, LLC	Watson Pharma, Inc.
ANHYDROUS LACTOSE(3SY5LH9PMK)
D&C YELLOW NO. 10(35SW5USQ3G)
ETHYLCELLULOSE, UNSPECIFIED(7Z8S9VYZ4B)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C RED NO. 40(WZB9127XOA)
FD&C YELLOW NO. 6(H77VEI93A8)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
LACTOSE(J2B2A4N98G)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POVIDONE K30(U725QWY32X)
POVIDONE K90(RDH86HJV5Z)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
POVIDONES(FZ989GH94E)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
STARCH, CORN(O8232NY3SJ)
TALC(7SEV7J4R1U)

Drug Product Composition: 17.alpha.-Ethynyl-19-nortestosterone