Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Safety Information For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

FDA Approval Activities for this Drug… Astelin (azelastine hydrochloride) Nasal Spray, Wallace NDA 20-114/S-005 5/30/00 6/6/00 Astelin Indications: Treatment of the symptoms of seasonal allergic sneezing, and nasal pruritus in adults and children 5 years and older (NOTE: Previously approved for 12 years and older). Astelin (azelastine hydrochloride) Nasal Spray, Wallace NDA 20-114/S-006 OPTIVAR (azelastine hydrochloride ophthalmic solution), 0.05%, ASTA Medica, NDA 21-127 5/22/00 5/23/00 5/23/00 2/15/02 Optivar Indications: Treatment of itching of the eye, associated with allergic conjunctivitis. AZELASTINE HYDROCHLORIDE Solution/Drops; Ophthalmic 0.05% OPTIVAR MEDPOINTE HLC 020114 AZELASTINE HYDROCHLORIDE Spray, Metered; Nasal 0.125MG BASE/SPRAY ASTELIN MEDPOINTE HLC OPTIVAR (azelastine hydrochloride ophthalmic solution), MedPointe, Labeling Revision | Astelin (azelastine hydrochloride) Nasal Spray, Medpointe Pharma, Labeling Revision | Azelastine Hydrochloride Nasal Spray, Apotex Inc., Tentative Approval | Optivar (azelastine hydrochloride) Ophthalmic Solution, Meda Pharmaceuticals, Inc., Package Change | Astepro (azelastine hydrochloride), MedPointe Pharmaceuticals, Nasal Spray, Approval | Azelastine Hydrochloride Ophthalmic Solution, Apotex Inc., Tentative Approval | Azelastine Hydrochloride Nasal Spray, Apotex Inc., Approval | Azelastine Hydrochloride Ophthalmic Solution, Sun Pharmaceutical Industries Ltd, Tentative Approval | Azelastine Hydrochloride Ophthalmic Solution, Apotex Inc., Approval | Astepro (azelastine hydrochloride) Nasal Spray, MEDA Pharmaceuticals, Approval | Azelastine Hydrochloride Ophthalmic Solution, Sun Pharmaceutical Industries, Inc., Approval | Astepro (azelastine hydrochloride) Nasal Spray, Meda Pharmaceuticals, Labeling Revision | Astelin, azelastine hydrochloride, Spray, Metered; Nasal, Meda Pharms, Labeling Revision ^ FDA's latest approval appears at the bottom of this list. ^                                                                       A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2012 Betterchem.com