Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019478
Company: BAYER PHARMS
Company: BAYER PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADALAT | NIFEDIPINE | 10MG | CAPSULE;ORAL | Discontinued | None | No | No |
| ADALAT | NIFEDIPINE | 20MG | CAPSULE;ORAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 11/27/1985 | ORIG-1 | Approval | Type 5 - New Formulation or New Manufacturer | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/22/1997 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/22/1996 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 09/22/1993 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 01/23/1992 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 09/13/1991 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 09/13/1991 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 11/21/1989 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 08/10/1989 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/26/1988 | SUPPL-4 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/21/1988 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/07/1986 | SUPPL-2 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 09/17/1986 | SUPPL-1 | Labeling |
Label is not available on this site. |