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- 0.03MG;1.5MG, TABLET;ORAL-21 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL - 11.25MG/VIAL,N/A;N/A,5MG, INJECTABLE, TABLET;INTRAMUSCULAR, ORAL -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TABLET;ORAL - 0.5MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1MG;0.5MG, TABLET;ORAL - 0.0025MG;0.5MG, TABLET;ORAL - 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.01MG,0.01MG;1MG,N/A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

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USFDA APPLICATION NUMBER - 17355 / DOSAGE - TABLET;ORAL-21 - 0.03MG;1.5MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ETHINYL ESTRADIOL(UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)	ETHINYL ESTRADIOL	0.02mg \| 0.03mg
NORETHINDRONE ACETATE(UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S)	NORETHINDRONE ACETATE	1mg \| 1.5mg

Inactive Ingredients

Ingredient Name	Aurobindo Pharma Limited	Actavis Pharma, Inc.	Mayne Pharma Inc.	RPK Pharmaceuticals, Inc.	Par Pharmaceutical
.ALPHA.-TOCOPHEROL(H4N855PNZ1)
ACACIA(5C5403N26O)
ALPHA-TOCOPHEROL(H4N855PNZ1)
CROSCARMELLOSE SODIUM(M28OL1HH48)
D&C YELLOW NO. 10(35SW5USQ3G)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C YELLOW NO. 6(H77VEI93A8)
FERROUS FUMARATE(R5L488RY0Q)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
LACTOSE(J2B2A4N98G)
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)
MAGNESIUM STEARATE(70097M6I30)
MANNITOL(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)
POVIDONE K30(U725QWY32X)
POVIDONE, UNSPECIFIED(FZ989GH94E)
RAW SUGAR(8M707QY5GH)
SILICON DIOXIDE(ETJ7Z6XBU4)
SODIUM LAURYL SULFATE(368GB5141J)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
STARCH, CORN(O8232NY3SJ)
SUCROSE(C151H8M554)
SUGARCANE(81H2R5AOH3)
TALC(7SEV7J4R1U)

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