NDA 20545, held by King Pharms. Procainamide Hydrochloride.
As of Nov 13, 2026, NDA 20545 (Procanbid), held by King Pharms, was first approved by FDA on Jan 31, 1996, with 6 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 31, 1996 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Procanbid500MG · tablet, extended release;oral | Procainamide Hydrochloride | Discontinued |
| Procanbid1GM · tablet, extended release;oral | Procainamide Hydrochloride | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 11, 2002 | Supplement 7Manufacturing · Standard review | Approved | |
| Jul 11, 2000 | Supplement 4Labeling · Standard review | Approved | None posted |
| Mar 11, 1999 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Feb 9, 1998 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Aug 7, 1997 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Dec 30, 1996 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 31, 1996 | Original applicationNew dosage form · Standard review | Approved |
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
