Details for New Drug Application (NDA): 207411
✉ Email this page to a colleague
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 207411
Tradename: | AZELASTINE HYDROCHLORIDE |
Applicant: | Somerset Theraps Llc |
Ingredient: | azelastine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 207411
Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 207411
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
AZELASTINE HYDROCHLORIDE | azelastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 207411 | ANDA | Somerset Therapeutics, LLC | 70069-091 | 70069-091-01 | 1 BOTTLE in 1 CARTON (70069-091-01) / 6 mL in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.05% | ||||
Approval Date: | Mar 29, 2019 | TE: | AT | RLD: | No |
Complete Access Available with Subscription