17.alpha.-Ethinyl-17.beta.-estradiol | 208612 | TABLET;ORAL | 0.02MG;0.1MG

17-alpha-Ethinyl-17-beta-estradiol

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

38 API Suppliers, 14 USDMF, 10 CEP/COS, 4 JDMF, 1 EU WC, 14 NDC API, 15 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

25 Drugs in Development

25 Drugs in Development

INTERMEDIATES

4 Intermediate Suppliers

4 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

729 FDF Dossiers, 418 FDA Orange Book, 107 Europe, 88 Canada, 56 South Africa, 60 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL-28 - 0.02MG;1MG, TABLET;ORAL-21 - 0.03MG;1.5MG, TABLET;ORAL-28 - 0.03MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.03MG;1.5MG, TABLET;ORAL-21 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A, CAPSULE;ORAL - 0.02MG;1MG, TABLET, CHEWABLE, TABLET;ORAL - 0.01MG,0.01MG,N/A;1MG,N/A,N/A, TABLET;ORAL - 0.02MG;0.1MG, RING;VAGINAL - 0.013MG/24HR;0.15MG/24HR, 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- 0.0025MG;0.5MG, TABLET;ORAL - 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG, FILM, EXTENDED RELEASE;TRANSDERMAL - 0.035MG/24HR;0.15MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, RING;VAGINAL - 0.015MG/24HR;0.12MG/24HR, TABLET;ORAL-28 - 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG **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;ORAL - 3MG;0.02MG, 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, TABLET, CHEWABLE;ORAL - 0.025MG;0.8MG

RELATED EXCIPIENT COMPANIES

2 Rochem International Inc, 5 SPI Pharma, 6 DKSH, 7 Faran Shimi Pharmaceutical, 4 Boai NKY Pharmaceuticals Ltd, 5 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 5 Actylis, 1 Aeon Procare, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 25 BASF, 2 Clariant, 11 Corel Pharma Chem, 7 DFE Pharma, 1 Doshion Polyscience, 1 Finar, 8 Gangwal Chemicals, 7 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 38 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 23 Roquette, 7 Seppic, 8 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 12 Sigachi Industries, 5 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 1 Valens Pharmachem, 5 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

74 Fillers, Diluents & Binders, 55 Coating Systems & Additives, 31 Controlled & Modified Release, 31 Disintegrants & Superdisintegrants, 26 Granulation, 26 Thickeners and Stabilizers, 25 Direct Compression, 20 Lubricants & Glidants, 16 Taste Masking, 16 Solubilizers, 13 Co-Processed Excipients, 12 Topical, 10 Film Formers & Plasticizers, 8 Parenteral, 7 Rheology Modifiers, 7 Chewable & Orodispersible Aids, 7 API Stability Enhancers, 6 Emulsifying Agents, 5 Coloring Agents, 5 Empty Capsules, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 152 News #PharmaBuzz

GLOBAL SALES INFORMATION

31 US Medicaid Prescriptions, 101 Regulatory FDF Prices, 22 Annual Reports

MARKET PLACE

17 APIs, 3 FDF Dossiers, 1 EXCIPIENTS

PATENTS & EXCLUSIVITIES

30 US Patents, 1 US Exclusivities, 5 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 2 USP, 3 JP, 3 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 208612 / DOSAGE - TABLET;ORAL - 0.02MG;0.1MG

Inactive Ingredients

Ingredient Name	Acella Pharmaceuticals	Avion Pharmaceuticals
CITRIC ACID MONOHYDRATE(2968PHW8QP)
CROSCARMELLOSE SODIUM(M28OL1HH48)
FD&C BLUE NO. 1(H3R47K3TBD)
FD&C RED NO. 40(WZB9127XOA)
FD&C YELLOW NO. 5(I753WB2F1M)
FD&C YELLOW NO. 6(H77VEI93A8)
FERROSOFERRIC OXIDE(XM0M87F357)
FERROUS BISGLYCINATE(SFW1D987QV)
GLYCINE(TE7660XO1C)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
LECITHIN, SOYBEAN(1DI56QDM62)
MAGNESIUM STEARATE(70097M6I30)
MALTODEXTRIN(7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL 3350(G2M7P15E5P)
POLYETHYLENE GLYCOL 400(B697894SGQ)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
SILICON DIOXIDE(ETJ7Z6XBU4)
STARCH, CORN(O8232NY3SJ)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
WATER(059QF0KO0R)

Drug Product Composition: 17.alpha.-Ethinyl-17.beta.-estradiol