Azelastine Hydrochloride

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ACTIVE PHARMA INGREDIENTS

24 API Suppliers, 14 USDMF, 6 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

2 API Suppliers

2 API 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SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - 0.137MG/SPRAY;0.05MG/SPRAY, SOLUTION/DROPS;OPHTHALMIC - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SPRAY, METERED;NASAL - 0.137MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Jai Radhe Sales, 1 Pharm-RX Chemical, 8 Gangwal Healthcare, 4 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, 16 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

15 APIs, 1 FDF Dossiers

PATENTS & EXCLUSIVITIES

14 US Patents

14 US Patents

REF. STANDARDS & IMPURITIES

4 EDQM, 4 USP, 13 Others

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USFDA APPLICATION NUMBER - 22203 / DOSAGE - SPRAY, METERED;NASAL - 0.137MG/SPRAY **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	205.5ug

Inactive Ingredients

Ingredient Name	A-S Medication Solutions	Meda Pharmaceuticals	Wallace Pharmaceuticals Inc.
BENZALKONIUM CHLORIDE(F5UM2KM3W7)
CITRIC ACID MONOHYDRATE(2968PHW8QP)
EDETATE DISODIUM(7FLD91C86K)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
SODIUM CHLORIDE(451W47IQ8X)
SODIUM CITRATE, UNSPECIFIED FORM(1Q73Q2JULR)
SODIUM PHOSPHATE, DIBASIC(GR686LBA74)
SORBITOL(506T60A25R)
SUCRALOSE(96K6UQ3ZD4)
WATER(059QF0KO0R)

Drug Product Composition: Azelastine Hydrochloride