Details for New Drug Application (NDA): 202305
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NDA 202305 describes AZELASTINE HYDROCHLORIDE, which is a drug marketed by Alembic, Apotex Inc, Epic Pharma Llc, Gland Pharma Ltd, Sandoz, Somerset Theraps Llc, Sun Pharm, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Bionpharma, Hikma, Padagis Israel, Sciegen Pharms Inc, Upsher Smith Labs, Zydus Pharms, and Apotex, and is included in twenty-eight NDAs. It is available from nineteen 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. Five 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. Five suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride; fluticasone propionate profile page.
Summary for 202305
| Tradename: | AZELASTINE HYDROCHLORIDE |
| Applicant: | Sandoz |
| Ingredient: | azelastine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 202305
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 202305
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AZELASTINE HYDROCHLORIDE | azelastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 202305 | ANDA | RPK Pharmaceuticals, Inc. | 53002-1803 | 53002-1803-1 | 1 BOTTLE, PLASTIC in 1 CARTON (53002-1803-1) / 6 mL in 1 BOTTLE, PLASTIC |
| AZELASTINE HYDROCHLORIDE | azelastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 202305 | ANDA | Sandoz Inc | 61314-308 | 61314-308-02 | 1 BOTTLE, PLASTIC in 1 CARTON (61314-308-02) / 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: | May 31, 2012 | TE: | AT | RLD: | No | ||||
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