Azelastine Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

39 API Suppliers, 14 USDMF, 7 CEP/COS, 2 JDMF, 4 EU WC, 12 KDMF, 14 NDC API, 14 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

15 Drugs in Development

15 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

161 FDF Dossiers, 40 FDA Orange Book, 100 Europe, 3 Canada, 3 South Africa, 15 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - 0.137MG/SPRAY;0.05MG/SPRAY, SOLUTION/DROPS;OPHTHALMIC - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

2 EUROAPI, 3 Rochem International Inc, 3 SPI Pharma, 4 DKSH, 1 Pharm-RX Chemical, 4 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 6 Kirsch Pharma, 1 ACG Worldwide, 11 Actylis, 2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Ashland, 1 BASF, 1 Bioplus Life Sciences, 1 CD Formulation, 10 Corel Pharma Chem, 2 DFE Pharma, 1 Finar, 8 Gangwal Chemicals, 4 Ideal Cures, 10 Kerry, 2 Keval Exports, 4 Kima Chemical, 6 Lonza Capsugel, 6 Microlex e.U, 1 Nanjing Bold Chemical, 1 Nitika Pharmaceutical Specialities, 1 Novo Excipients, 1 Pharmatrans-Sanaq, 2 Pluviaendo, 1 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 18 Roquette, 12 Seppic, 2 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 8 Sigachi Industries, 1 Silverline Chemicals, 3 The Dow Chemical Company, 1 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

41 Coating Systems & Additives, 23 Thickeners and Stabilizers, 23 Fillers, Diluents & Binders, 21 Parenteral, 17 Film Formers & Plasticizers, 16 Solubilizers, 16 Controlled & Modified Release, 11 Taste Masking, 11 Direct Compression, 9 Rheology Modifiers, 9 Co-Processed Excipients, 7 Granulation, 6 Chewable & Orodispersible Aids, 6 Disintegrants & Superdisintegrants, 5 Topical, 5 Empty Capsules, 4 Emulsifying Agents, 4 Vegetarian Capsules, 4 API Stability Enhancers, 3 Surfactant & Foaming Agents, 2 Coloring Agents, 1 Lubricants & Glidants, 1 Soft Gelatin

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 35 News #PharmaBuzz

GLOBAL SALES INFORMATION

19 US Medicaid Prescriptions, 15 Regulatory FDF Prices, 14 Annual Reports

MARKET PLACE

16 APIs, 1 FDF Dossiers

PATENTS & EXCLUSIVITIES

13 US Patents, 2 Health Canada Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 16 Others

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USFDA APPLICATION NUMBER - 21127 / DOSAGE - SOLUTION/DROPS;OPHTHALMIC - 0.05% **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
AZELASTINE HYDROCHLORIDE(UNII: 0L591QR10I) (AZELASTINE - UNII:ZQI909440X)	AZELASTINE HYDROCHLORIDE	0.5mg in 1

Inactive Ingredients

Ingredient Name	Meda Pharmaceuticals Inc.	Wallace Pharmaceuticals Inc.
BENZALKONIUM CHLORIDE(F5UM2KM3W7)
EDETATE DISODIUM(7FLD91C86K)
HYPROMELLOSES(3NXW29V3WO)
SODIUM HYDROXIDE(55X04QC32I)
SORBITOL(506T60A25R)
WATER(059QF0KO0R)

Setid F2f72f86 C1c8 11df 851a 0800200c9a66 Applno 21127 Form Solution Drops Ophthalmic Dosage 0 05 - Drug Product Composition: Azelastine Hydrochloride