Details for New Drug Application (NDA): 077954
✉ Email this page to a colleague
NDA 077954 describes AZELASTINE HYDROCHLORIDE, which is a drug marketed by Alembic, Apotex, Epic Pharma Llc, Gland, Sandoz, Somerset Theraps Llc, Sun Pharm, Alkem Labs Ltd, Amneal, Apotex Inc, Aurobindo Pharma Ltd, Bionpharma, Hikma, Padagis Israel, Padagis Us, Sciegen Pharms Inc, Zydus Pharms, Aurobindo Pharma, and Teva Pharms Usa Inc, and is included in thirty NDAs. It is available from seventeen suppliers. Additional details are available on the AZELASTINE HYDROCHLORIDE profile page.
The generic ingredient in AZELASTINE HYDROCHLORIDE is azelastine hydrochloride; fluticasone propionate. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride; fluticasone propionate profile page.
The generic ingredient in AZELASTINE HYDROCHLORIDE is azelastine hydrochloride; fluticasone propionate. There are twelve drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride; fluticasone propionate profile page.
Summary for 077954
| Tradename: | AZELASTINE HYDROCHLORIDE |
| Applicant: | Apotex Inc |
| Ingredient: | azelastine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 077954
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 077954
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AZELASTINE HYDROCHLORIDE | azelastine hydrochloride | SPRAY, METERED;NASAL | 077954 | ANDA | A-S Medication Solutions | 50090-2330 | 50090-2330-0 | 1 BOTTLE, SPRAY in 1 CARTON (50090-2330-0) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY |
| AZELASTINE HYDROCHLORIDE | azelastine hydrochloride | SPRAY, METERED;NASAL | 077954 | ANDA | Apotex Corp. | 60505-0833 | 60505-0833-5 | 1 BOTTLE, SPRAY in 1 CARTON (60505-0833-5) / 200 SPRAY, METERED in 1 BOTTLE, SPRAY |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 0.137MG/SPRAY | ||||
| Approval Date: | Apr 30, 2009 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
