Details for New Drug Application (NDA): 008883
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NDA 008883 describes OPHTHAINE, which is a drug marketed by Apothecon and is included in one NDA. Additional details are available on the OPHTHAINE profile page.
The generic ingredient in OPHTHAINE is proparacaine hydrochloride. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the proparacaine hydrochloride profile page.
The generic ingredient in OPHTHAINE is proparacaine hydrochloride. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the proparacaine hydrochloride profile page.
Summary for 008883
| Tradename: | OPHTHAINE |
| Applicant: | Apothecon |
| Ingredient: | proparacaine hydrochloride |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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