NDA 60014, held by Casper Pharma LLC. Penicillin G Benzathine.
As of Nov 13, 2026, NDA 60014 (Permapen), held by Casper Pharma LLC, was first approved by FDA on Dec 16, 1952, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 16, 1952 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Permapen600,000 UNITS/ML ยท injectable;injection | Penicillin G Benzathine | Discontinued |
| Feb 18, 2000 | Supplement 2Labeling | Approved | None posted |
| Aug 8, 1989 | Supplement 1Manufacturing | Approved | None posted |
| Dec 16, 1952 | 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