Details for New Drug Application (NDA): 021127
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The generic ingredient in OPTIVAR is azelastine hydrochloride. There are twelve drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride profile page.
Summary for 021127
Tradename: | OPTIVAR |
Applicant: | Mylan Speciality Lp |
Ingredient: | azelastine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
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| SOLUTION/DROPS;OPHTHALMIC | Strength | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 |
---|---|---|---|---|---|---|---|
Mylan Speciality Lp | OPTIVAR | azelastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 021127-001 | May 22, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Mylan Speciality Lp | OPTIVAR | azelastine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 021127-001 | May 22, 2000 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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