Details for New Drug Application (NDA): 078738
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The generic ingredient in AZELASTINE HYDROCHLORIDE is azelastine hydrochloride; fluticasone propionate. There are twelve drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride; fluticasone propionate profile page.
Summary for 078738
Tradename: | AZELASTINE HYDROCHLORIDE |
Applicant: | Sun Pharm |
Ingredient: | azelastine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 078738
Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 078738
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AZELASTINE HYDROCHLORIDE | azelastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 078738 | ANDA | Sun Pharmaceutical Industries, Inc. | 47335-938 | 47335-938-90 | 1 BOTTLE, PLASTIC in 1 BOX (47335-938-90) / 6 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.05% | ||||
Approval Date: | Jun 21, 2010 | TE: | AT | RLD: | No |
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