Treats superficial bacterial infections of the external auditory canal caused by…. NDA 60613, held by Casper Pharma LLC. Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate.
As of Nov 13, 2026, NDA 60613 (Casporyn Hc), held by Casper Pharma LLC, was first approved by FDA on May 25, 1975, with 8 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE For the treatment of superficial bacterial infections of the external auditory canal caused by organisms susceptible to the action of the antibiotics, and for the treatment of infections of mastoidectomy and fenestration cavities caused by organisms susceptible to the antibiotics.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 25, 1975 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Casporyn Hc1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML · suspension/drops;otic | Hydrocortisone; Neomycin Sulfate; Polymyxin B Sulfate | RxReference drug |
| Mar 15, 2019 | Supplement 14Manufacturing · Standard review | Approved | |
| Dec 19, 2017 | Supplement 13Labeling · Standard review | Approved | |
| Aug 10, 2000 | Supplement 8Labeling | Approved | None posted |
| Aug 10, 2000 | Supplement 9Labeling | Approved | None posted |
| Jul 23, 1999 | Supplement 10Manufacturing | Approved | None posted |
| Feb 14, 1995 | Supplement 7Manufacturing | Approved | None posted |
| Mar 30, 1993 | Supplement 5Labeling | Approved | None posted |
| Feb 4, 1988 | Supplement 4Labeling | Approved | None posted |
| May 25, 1975 | 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
