NDA 19478, held by Bayer Pharms. Nifedipine.
As of Nov 13, 2026, NDA 19478 (Adalat), held by Bayer Pharms, was first approved by FDA on Nov 27, 1985, with 12 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 27, 1985 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Adalat10MG · capsule;oral | Nifedipine | Discontinued |
| Adalat20MG · capsule;oral | Nifedipine | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 22, 1997 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Mar 22, 1996 | Supplement 11Labeling · Standard review | Approved | None posted |
| Sep 22, 1993 | Supplement 10Labeling · Standard review | Approved | None posted |
| Jan 23, 1992 | Supplement 9Labeling · Standard review | Approved | None posted |
| Sep 13, 1991 | Supplement 8Labeling · Standard review | Approved | None posted |
| Sep 13, 1991 | Supplement 7Labeling · Standard review | Approved | None posted |
| Nov 21, 1989 | Supplement 6Labeling · Standard review | Approved | None posted |
| Aug 10, 1989 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Oct 26, 1988 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Jul 21, 1988 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Oct 7, 1986 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Sep 17, 1986 | Supplement 1Labeling · Standard review | Approved | None posted |
| Nov 27, 1985 | Original applicationNew formulation or manufacturer · Standard review | 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
