ANDA 80364, held by Parke Davis. Meperidine Hydrochloride.
As of Nov 15, 2026, ANDA 80364 (Meperidine Hydrochloride), held by Parke Davis, was first approved by FDA on May 19, 1976, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 19, 1976 | Original application | Approved | None posted |
| Meperidine Hydrochloride100MG/ML · injectable;injection | Meperidine Hydrochloride | Discontinued |
| Meperidine Hydrochloride50MG/ML · injectable;injection | Meperidine Hydrochloride | Discontinued |
| Meperidine Hydrochloride75MG/ML · injectable;injection | Meperidine Hydrochloride | Discontinued |
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
