Azelastine Hydrochloride

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

24 API Suppliers, 14 USDMF, 7 CEP/COS, 2 JDMF, 4 EU WC, 14 KDMF, 13 NDC API, 11 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

2 Drugs in Development

2 Drugs in Development

INTERMEDIATES

3 Intermediates Suppliers

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

84 FDF Dossiers, 39 FDA Orange Book, 27 Europe, 3 Canada, 3 South Africa, 12 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SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - 0.137MG/SPRAY;0.05MG/SPRAY, SOLUTION/DROPS;OPHTHALMIC - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

3 Rochem International Inc, 3 SPI Pharma, 1 DKSH, 1 Pharm-RX Chemical, 1 Faran Shimi Pharmaceutical, 8 Gangwal Healthcare, 2 Nanjing Well Pharmaceutical, 1 ACG Worldwide, 11 Actylis, 2 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 BASF, 1 Bioplus Life Sciences, 10 Corel Pharma Chem, 2 DFE Pharma, 1 Finar, 8 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 15 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 6 Microlex e.U, 1 Nanjing Bold Chemical, 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, 3 The Dow Chemical Company, 1 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

45 Coating Systems & Additives, 23 Fillers, Diluents & Binders, 22 Controlled & Modified Release, 18 Film Formers & Plasticizers, 17 Thickeners and Stabilizers, 16 Solubilizers, 16 Direct Compression, 14 Parenteral, 10 Co-Processed Excipients, 10 Taste Masking, 7 Disintegrants & Superdisintegrants, 7 Granulation, 6 Rheology Modifiers, 5 Empty Capsules, 5 Chewable & Orodispersible Aids, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Emulsifying Agents, 4 Topical, 2 Surfactant & Foaming Agents, 2 Coloring Agents, 2 Lubricants & Glidants, 1 Soft Gelatin

DIGITAL CONTENT

35 NEWS #PharmaBuzz

35 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 20 Finished Drug Prices, 2 Annual Reports

MARKET PLACE

16 APIs, 1 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 US Patents

14 US Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 4 USP, 13 Others

$ Xls

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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)

Drug Product Composition: Azelastine Hydrochloride