ANDA 81309, held by Intl Medication. Meperidine Hydrochloride.
As of Nov 15, 2026, ANDA 81309 (Meperidine Hydrochloride Preservative Free), held by Intl Medication, was first approved by FDA on Aug 30, 1993, with 13 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 30, 1993 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Meperidine Hydrochloride Preservative Free10MG/ML · injectable;injection | Meperidine Hydrochloride | Discontinued |
| Dec 22, 2025 | Supplement 13Labeling · Standard review | Approved | None posted |
| Dec 22, 2025 | Supplement 12Labeling · Standard review | Approved | None posted |
| Dec 15, 2023 | Supplement 11Labeling · Standard review | Approved | None posted |
| Oct 11, 2019 | Supplement 10Labeling · Standard review | Approved | None posted |
| Sep 27, 2019 | Supplement 9Labeling · Standard review | Approved | None posted |
| Dec 16, 2016 | Supplement 8Labeling · Standard review | Approved | None posted |
| Dec 16, 2016 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jan 14, 1998 | Supplement 1Manufacturing | Approved | None posted |
| Sep 19, 1995 | Supplement 6Manufacturing | Approved | None posted |
| Jul 25, 1995 | Supplement 5Manufacturing | Approved | None posted |
| Jun 17, 1994 | Supplement 4Manufacturing | Approved | None posted |
| Apr 18, 1994 | Supplement 3Labeling | Approved | None posted |
| Apr 18, 1994 | Supplement 2Manufacturing | Approved | None posted |
| Aug 30, 1993 | 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
