(4S)-6-Chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-benzo[d][1,3]oxazin-2-one

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

51 API Suppliers, 28 USDMF, 8 EU WC, 2 KDMF, 20 NDC API, 19 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

52 Drugs in Development

52 Drugs in Development

INTERMEDIATES

5 Intermediate Suppliers

5 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

235 FDF Dossiers, 59 FDA Orange Book, 79 Europe, 8 Canada, 1 Australia, 67 South Africa, 21 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 400MG;300MG;300MG, CAPSULE;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 600MG;200MG;300MG

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 10 DKSH, 5 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 4 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 14 BASF, 10 Corel Pharma Chem, 6 DFE Pharma, 1 Esteem Industries, 1 Finar, 7 Gangwal Chemicals, 5 Ideal Cures, 2 Ingredion Pharma Solutions, 21 Kerry, 3 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 10 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 4 Pluviaendo, 4 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 12 Roquette, 7 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 4 Silverline Chemicals, 2 The Dow Chemical Company, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

47 Coating Systems & Additives, 36 Fillers, Diluents & Binders, 24 Disintegrants & Superdisintegrants, 23 Controlled & Modified Release, 21 Thickeners and Stabilizers, 20 Granulation, 16 Lubricants & Glidants, 15 Direct Compression, 11 Topical, 9 Empty Capsules, 8 Co-Processed Excipients, 7 Film Formers & Plasticizers, 6 Taste Masking, 5 API Stability Enhancers, 5 Coloring Agents, 5 Solubilizers, 5 Rheology Modifiers, 4 Chewable & Orodispersible Aids, 4 Vegetarian Capsules, 4 Emulsifying Agents, 3 Parenteral, 1 Surfactant & Foaming Agents

DIGITAL CONTENT

55 News #PharmaBuzz

55 News #PharmaBuzz

GLOBAL SALES INFORMATION

17 US Medicaid Prescriptions, 19 Regulatory FDF Prices, 15 Annual Reports

MARKET PLACE

9 APIs, 5 FDF Dossiers

PATENTS & EXCLUSIVITIES

5 US Patents, 18 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 USP, 9 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

$ Xls

Filters

Xls

USFDA APPLICATION NUMBER - 21360 / DOSAGE - TABLET;ORAL - 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
efavirenz(UNII: JE6H2O27P8) (efavirenz - UNII:JE6H2O27P8)	efavirenz	600mg

Inactive Ingredients

Ingredient Name	A-S Medication Solutions	REMEDYREPACK INC.
CARNAUBA WAX(R12CBM0EIZ)
cellulose, microcrystalline(OP1R32D61U)
CROSCARMELLOSE SODIUM(M28OL1HH48)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
sodium lauryl sulfate(368GB5141J)

Setid 9d8498bd 7744 4428 A8bf C6d3a97e2817 Applno 21360 Form Tablet Oral Dosage 600mg - Drug Product Composition: (4S)-6-Chloro-4-cyclopropylethynyl-4-trifluoromethyl-1,4-dihydro-benzo[d][1,3]oxazin-2-one