Details for New Drug Application (NDA): 012583
✉ Email this page to a colleague
NDA 012583 describes OPHTHETIC, which is a drug marketed by Allergan and is included in one NDA. Additional details are available on the OPHTHETIC profile page.
The generic ingredient in OPHTHETIC 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 OPHTHETIC 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 012583
| Tradename: | OPHTHETIC |
| Applicant: | Allergan |
| 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| SOLUTION/DROPS;OPHTHALMIC | Strength | 0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 | |||||
Complete Access Available with Subscription
