NDA 50416, held by Casper Pharma LLC. Bacitracin Zinc; Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate.
As of Nov 13, 2026, NDA 50416 (Cortisporin), held by Casper Pharma LLC, was first approved by FDA on May 10, 1971, with 10 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 10, 1971 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cortisporin400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · ointment;ophthalmic | Bacitracin Zinc; Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 22, 2004 | Supplement 15Labeling · Standard review | Approved | |
| Apr 19, 1999 | Supplement 14Manufacturing | Approved | None posted |
| Jun 23, 1998 | Supplement 13Manufacturing | Approved | None posted |
| Jun 13, 1995 | Supplement 12Manufacturing | Approved | None posted |
| Feb 9, 1995 | Supplement 11Manufacturing | Approved | None posted |
| Dec 22, 1994 | Supplement 10Manufacturing | Approved | None posted |
| May 10, 1994 | Supplement 6Labeling | Approved | None posted |
| Sep 22, 1993 | Supplement 9Manufacturing | Approved | None posted |
| Mar 23, 1993 | Supplement 8Manufacturing | Approved | None posted |
| Aug 10, 1992 | Supplement 7Manufacturing | Approved | None posted |
| May 10, 1971 | Original application | 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
