(8R,9S,13S,14S,17R)-17-ethynyl-13-methyl-7,8,9,11,12,13,14,15,16,17-decahydro-6H-cyclopenta[a]phenanthrene-3,17-diol

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ACTIVE PHARMA INGREDIENTS

43 API Suppliers, 15 USDMF, 11 CEP/COS, 4 JDMF, 4 EU WC, 13 NDC API, 17 Listed Suppliers

DEVELOPMENTS

63 Drugs in Development

63 Drugs in Development

INTERMEDIATES

4 Intermediate Suppliers

4 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

1388 FDF Dossiers, 421 FDA Orange Book, 731 Europe, 108 Canada, 34 Australia, 60 South Africa, 34 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL-28 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.03MG;1.5MG, TABLET;ORAL-28 - 0.03MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.03MG;1.5MG, TABLET;ORAL-21 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL-21 - 0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A, CAPSULE;ORAL - 0.02MG;1MG, TABLET, CHEWABLE,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

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EXCIPIENTS BY APPLICATIONS

59 Fillers, Diluents & Binders, 48 Coating Systems & Additives, 31 Granulation, 30 Direct Compression, 29 Disintegrants & Superdisintegrants, 26 Controlled & Modified Release, 24 Thickeners and Stabilizers, 20 Lubricants & Glidants, 17 Solubilizers, 15 Taste Masking, 13 Co-Processed Excipients, 13 Topical, 9 Film Formers & Plasticizers, 8 Parenteral, 8 Chewable & Orodispersible Aids, 7 API Stability Enhancers, 6 Emulsifying Agents, 5 Empty Capsules, 5 Rheology Modifiers, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents, 2 Coloring Agents

DIGITAL CONTENT

2 Data Compilation #PharmaFlow, 156 News #PharmaBuzz

GLOBAL SALES INFORMATION

143 US Medicaid Prescriptions, 45 Regulatory FDF Prices, 41 Annual Reports

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17 APIs, 3 FDF Dossiers, 1 EXCIPIENTS

PATENTS & EXCLUSIVITIES

30 US Patents, 1 US Exclusivities, 29 Health Canada Patents

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ANALYTICAL

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1 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 19653 / DOSAGE - TABLET;ORAL-28 - 0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Inactive Ingredients

Ingredient Name	Janssen Pharmaceuticals, Inc.	Proficient Rx LP	RPK Pharmaceuticals, Inc.
ALUMINUM OXIDE(LMI26O6933)
CARNAUBA WAX(R12CBM0EIZ)
Croscarmellose Sodium(M28OL1HH48)
FD&C BLUE No. 2(L06K8R7DQK)
FERRIC OXIDE RED(1K09F3G675)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)
MAGNESIUM STEARATE(70097M6I30)
Microcrystalline Cellulose(OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)
Polysorbate 80(6OZP39ZG8H)
POLYVINYL ALCOHOL, UNSPECIFIED(532B59J990)
STARCH, CORN(O8232NY3SJ)
TALC(7SEV7J4R1U)
Titanium Dioxide(15FIX9V2JP)
Water(059QF0KO0R)

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Setid 7e6ff7b1 Bd5c 475c A6af Eac7f10fd2ea Applno 19653 Form Tablet Oral 28 Dosage 0 035mg 0 25mg - Drug Product Composition: (8R,9S,13S,14S,17R)-17-ethynyl-13-methyl-7,8,9,11,12,13,14,15,16,17-decahydro-6H-cyclopenta[a]phenanthrene-3,17-diol