NDA 16844, held by Aaipharma LLC. Acetaminophen; Propoxyphene Hydrochloride.
As of Nov 13, 2026, NDA 16844 (Darvocet), held by Aaipharma LLC, was first approved by FDA on Oct 18, 1972, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 18, 1972 | Original applicationNew combination · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Darvocet325MG;32.5MG · tablet;oral | Acetaminophen; Propoxyphene 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
