NDA 8883, held by Apothecon. Proparacaine Hydrochloride.
As of Nov 13, 2026, NDA 8883 (Ophthaine), held by Apothecon, was first approved by FDA on Jul 1, 1953, with 10 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 1, 1953 | Original applicationNew molecular entity · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ophthaine0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution/drops;ophthalmic | Proparacaine Hydrochloride | DiscontinuedReference drug |
| Aug 8, 1988 | Supplement 14Manufacturing · Standard review | Approved | None posted |
| Nov 5, 1986 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jul 26, 1985 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| May 3, 1984 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Mar 22, 1983 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| May 8, 1982 | Supplement 9Labeling | Approved | None posted |
| Oct 4, 1979 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Sep 28, 1978 | Supplement 5Labeling | Approved | None posted |
| Sep 28, 1978 | Supplement 6Labeling | Approved | None posted |
| Aug 24, 1978 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jul 1, 1953 | Original applicationNew molecular entity · Standard review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
