Darifenacin Hydrobromide

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ACTIVE PHARMA INGREDIENTS

24 API Suppliers, 14 USDMF, 7 EU WC, 7 NDC API, 12 Listed Suppliers, $ API Reference Price

INTERMEDIATES

8 Intermediate Suppliers

8 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

55 FDF Dossiers, 20 FDA Orange Book, 14 Europe, 6 Canada, 5 South Africa, 10 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - EQ 7.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 SPI Pharma, 5 DKSH, 3 Boai NKY Pharmaceuticals Ltd, 3 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 3 Actylis, 1 Aeon Procare, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 9 BASF, 3 Clariant, 10 Corel Pharma Chem, 4 DFE Pharma, 1 Esteem Industries, 1 Finar, 8 Gangwal Chemicals, 5 Ideal Cures, 21 Kerry, 1 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 10 Microlex e.U, 2 Nitika Pharmaceutical Specialities, 2 Nomisma Healthcare, 2 Novo Excipients, 1 Pharmatrans-Sanaq, 2 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 9 Roquette, 6 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 9 Sigachi Industries, 2 Silverline Chemicals, 2 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

45 Coating Systems & Additives, 38 Fillers, Diluents & Binders, 22 Controlled & Modified Release, 18 Thickeners and Stabilizers, 16 Lubricants & Glidants, 15 Topical, 14 Granulation, 14 Direct Compression, 10 Film Formers & Plasticizers, 10 Co-Processed Excipients, 8 Solubilizers, 6 Disintegrants & Superdisintegrants, 6 API Stability Enhancers, 5 Empty Capsules, 5 Emulsifying Agents, 5 Rheology Modifiers, 5 Parenteral, 4 Vegetarian Capsules, 4 Taste Masking, 4 Coloring Agents, 4 Chewable & Orodispersible Aids, 2 Surfactant & Foaming Agents

DIGITAL CONTENT

12 News #PharmaBuzz

12 News #PharmaBuzz

GLOBAL SALES INFORMATION

6 US Medicaid Prescriptions, 6 Regulatory FDF Prices, 2 Annual Reports

MARKET PLACE

2 APIs, 4 FDF Dossiers

PATENTS & EXCLUSIVITIES

6 Health Canada Patents

6 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 Others

4 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 21513 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 15MG 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
DARIFENACIN(UNII: APG9819VLM) (DARIFENACIN - UNII:APG9819VLM)	DARIFENACIN	15mg

Inactive Ingredients

Ingredient Name	Actavis Pharma, Inc.	Allergan, Inc.	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J)
FERRIC OXIDE RED(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
HYPROMELLOSES(3NXW29V3WO)
MAGNESIUM STEARATE(70097M6I30)
POLYETHYLENE GLYCOL 200(R95B8J264J)
POLYETHYLENE GLYCOL(3WJQ0SDW1A)
TALC(7SEV7J4R1U)
TITANIUM DIOXIDE(15FIX9V2JP)

Setid Cec47488 Ebad 4a3a 904c E916b432e2cf Applno 21513 Form Tablet Extended Release Oral Dosage Eq 15mg Base - Drug Product Composition: Darifenacin Hydrobromide