Details for New Drug Application (NDA): 021127
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NDA 021127 describes OPTIVAR, which is a drug marketed by Norvium Bioscience and is included in one NDA. Additional details are available on the OPTIVAR profile page.
The generic ingredient in OPTIVAR is azelastine hydrochloride. There are twelve drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride profile page.
The generic ingredient in OPTIVAR is azelastine hydrochloride. There are twelve drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride profile page.
Summary for 021127
| Tradename: | OPTIVAR |
| Applicant: | Norvium Bioscience |
| Ingredient: | azelastine hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | May 22, 2000 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 021127
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Norvium Bioscience | OPTIVAR | azelastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 021127-001 | May 22, 2000 | 5,164,194*PED | ⤷ Try for Free |
| Norvium Bioscience | OPTIVAR | azelastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 021127-001 | May 22, 2000 | 5,164,194 | ⤷ Try for Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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