Rosiglitazone Maleate

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ACTIVE PHARMA INGREDIENTS

10 API Suppliers, 9 USDMF, 1 NDC API, 2 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 Drugs in Development

FINISHED DOSAGE FORMULATIONS

64 FDF Dossiers, 42 FDA Orange Book, 18 Europe, 3 Canada, 1 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 2 DKSH, 4 Gangwal Healthcare, 2 Kewpie Corporation, 4 Nanjing Well Pharmaceutical, 1 Aeon Procare, 3 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 BASF, 1 Clariant, 5 Corel Pharma Chem, 5 DFE Pharma, 6 Gangwal Chemicals, 2 Ideal Cures, 1 Ingredion Pharma Solutions, 13 Kerry, 2 Keval Exports, 9 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 2 Pluviaendo, 3 Prachin Chemical, 11 Roquette, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 10 Sigachi Industries, 3 Silverline Chemicals, 3 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

29 Fillers, Diluents & Binders, 20 Coating Systems & Additives, 14 Disintegrants & Superdisintegrants, 13 Lubricants & Glidants, 12 Granulation, 12 Direct Compression, 10 Thickeners and Stabilizers, 8 Co-Processed Excipients, 8 Controlled & Modified Release, 7 Film Formers & Plasticizers, 5 Parenteral, 4 Topical, 4 Emulsifying Agents, 3 Taste Masking, 3 Chewable & Orodispersible Aids, 2 Coloring Agents, 2 Rheology Modifiers, 1 API Stability Enhancers, 1 Surfactant & Foaming Agents, 1 Solubilizers

DIGITAL CONTENT

3 News #PharmaBuzz

3 News #PharmaBuzz

PATENTS & EXCLUSIVITIES

8 Health Canada Patents

8 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 USP, 1 Others

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USFDA APPLICATION NUMBER - 21071 / DOSAGE - TABLET;ORAL - EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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
ROSIGLITAZONE MALEATE(UNII: KX2339DP44) (ROSIGLITAZONE - UNII:05V02F2KDG)	ROSIGLITAZONE MALEATE	8mg \| 4mg

Inactive Ingredients

Ingredient Name	Cardinal Health	GlaxoSmithKline Inc	GlaxoSmithKline LLC
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
HYPROMELLOSE 2910 (3 MPA.S)(0VUT3PMY82)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLYETHYLENE GLYCOL 3000(SA1B764746)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)
TRIACETIN(XHX3C3X673)

Setid 28c31e58 0b27 43e2 Bae0 9bbb21420e9f Applno 21071 Form Tablet Oral Dosage Eq 2mg Base - Drug Product Composition: Rosiglitazone Maleate