Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018869
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NIMOTOP NIMODIPINE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No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

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