Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018869
Company: BAYER PHARMS
Company: BAYER PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| NIMOTOP | NIMODIPINE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 12/28/1988 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/20/2006 | SUPPL-14 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018869s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018869s014ltr.pdf | |
| 08/21/2000 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/22/2000 | SUPPL-10 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/18869SE10lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/18869S10LTR.PDF | |
| 12/15/1999 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 04/18/1997 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/24/1996 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 09/02/1994 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/16/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 08/12/1991 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 12/07/1990 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 10/26/1989 | SUPPL-2 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/24/1989 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/20/2006 | SUPPL-14 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018869s014lbl.pdf | |
| 08/22/2000 | SUPPL-10 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/18869SE10lbl.pdf |