Suppliers and packages for tradename: AZELASTINE HYDROCHLORIDE
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AZELASTINE HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Alembic | AZELASTINE HYDROCHLORIDE | azelastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 209620 | ANDA | Alembic Pharmaceuticals Inc. | 62332-506-06 | 1 BOTTLE in 1 CARTON (62332-506-06) / 6 mL in 1 BOTTLE | 2019-03-20 |
| Apotex Inc | AZELASTINE HYDROCHLORIDE | azelastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 078621 | ANDA | Apotex Corp. | 60505-0578-4 | 1 BOTTLE, PLASTIC in 1 CARTON (60505-0578-4) / 6 mL in 1 BOTTLE, PLASTIC | 2009-12-01 |
| Gland Pharma Ltd | AZELASTINE HYDROCHLORIDE | azelastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 210092 | ANDA | Gland Pharma Limited | 68083-287-01 | 1 BOTTLE, PLASTIC in 1 BOX (68083-287-01) / 6 mL in 1 BOTTLE, PLASTIC | 2020-02-25 |
| Sandoz | AZELASTINE HYDROCHLORIDE | azelastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 202305 | ANDA | RPK Pharmaceuticals, Inc. | 53002-1803-1 | 1 BOTTLE, PLASTIC in 1 CARTON (53002-1803-1) / 6 mL in 1 BOTTLE, PLASTIC | 2013-03-21 |
| Sandoz | AZELASTINE HYDROCHLORIDE | azelastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 202305 | ANDA | Sandoz Inc | 61314-308-02 | 1 BOTTLE, PLASTIC in 1 CARTON (61314-308-02) / 6 mL in 1 BOTTLE, PLASTIC | 2013-03-21 |
| Somerset Theraps Llc | AZELASTINE HYDROCHLORIDE | azelastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 207411 | ANDA | Somerset Therapeutics, LLC | 70069-091-01 | 1 BOTTLE in 1 CARTON (70069-091-01) / 6 mL in 1 BOTTLE | 2019-04-08 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
