Atazanavir Sulfate

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ACTIVE PHARMA INGREDIENTS

44 API Suppliers, 25 USDMF, 7 CEP/COS, 10 EU WC, 2 KDMF, 18 NDC API, 21 Listed Suppliers, $ API Reference Price

FINISHED DOSAGE FORMULATIONS

75 FDF Dossiers, 42 FDA Orange Book, 14 Europe, 11 Canada, 2 South Africa, 6 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 300MG BASE;150MG, CAPSULE;ORAL - EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, CAPSULE;ORAL - EQ 200MG BASE, CAPSULE;ORAL - EQ 300MG BASE

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 1 SPI Pharma, 8 DKSH, 5 Gangwal Healthcare, 3 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 2 Kirsch Pharma, 4 ACG Worldwide, 1 Actylis, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 8 BASF, 6 DFE Pharma, 1 Finar, 6 Gangwal Chemicals, 1 Ideal Cures, 2 Ingredion Pharma Solutions, 10 Kerry, 3 Keval Exports, 3 Lonza Capsugel, 12 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 2 Pharmatrans-Sanaq, 4 Pluviaendo, 4 Prachin Chemical, 1 Qualicaps, 14 Roquette, 3 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 4 Silverline Chemicals, 1 Valens Pharmachem, 4 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

34 Fillers, Diluents & Binders, 22 Disintegrants & Superdisintegrants, 21 Thickeners and Stabilizers, 18 Granulation, 16 Lubricants & Glidants, 15 Direct Compression, 13 Coating Systems & Additives, 8 Co-Processed Excipients, 8 Film Formers & Plasticizers, 8 Empty Capsules, 8 Emulsifying Agents, 7 Taste Masking, 7 Topical, 4 Controlled & Modified Release, 4 Chewable & Orodispersible Aids, 4 Parenteral, 4 Solubilizers, 3 Surfactant & Foaming Agents, 3 Coloring Agents, 2 Rheology Modifiers, 1 API Stability Enhancers

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PATENTS & EXCLUSIVITIES

2 US Patents, 12 Health Canada Patents

REF. STANDARDS & IMPURITIES

7 USP, 1 Others

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USFDA APPLICATION NUMBER - 21567 / DOSAGE - CAPSULE;ORAL - EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
ATAZANAVIR SULFATE(UNII: 4MT4VIE29P) (ATAZANAVIR - UNII:QZU4H47A3S)	ATAZANAVIR	200mg \| 300mg

Inactive Ingredients

Ingredient Name	A-S Medication Solutions	A-S Medication Solutions LLC	Greenstone LLC	REMEDYREPACK INC.
ALCOHOL(3K9958V90M)
AMMONIA(5138Q19F1X)
BUTYL ALCOHOL(8PJ61P6TS3)
CROSPOVIDONE (15 MPA.S AT 5%)(68401960MK)
CROSPOVIDONE(68401960MK)
FD&C BLUE NO. 2(L06K8R7DQK)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
FERROSOFERRIC OXIDE(XM0M87F357)
GELATIN(2G86QN327L)
GELATIN, UNSPECIFIED(2G86QN327L)
ISOPROPYL ALCOHOL(ND2M416302)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
PROPYLENE GLYCOL(6DC9Q167V3)
SHELLAC(46N107B71O)
TITANIUM DIOXIDE(15FIX9V2JP)

Setid De96add2 7e96 4633 B205 19b3434010ce Applno 21567 Form Capsule Oral Dosage Eq 100mg Base - Drug Product Composition: Atazanavir Sulfate