Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 009000
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CAFERGOT CAFFEINE; ERGOTAMINE TARTRATE 100MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SUPPOSITORY;RECTAL Discontinued None Yes No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
04/24/1953 ORIG-1 Approval Type 4 - New Combination 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
11/07/2001 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

04/02/2001 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

03/29/2001 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/2000 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

06/04/2002 SUPPL-23 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/9000s22s23lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/9000s022ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/09000_S022&S023_Cafergot_APPROVAL PACKAGE.pdf
06/04/2002 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/9000s22s23lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/9000s022ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/09000_S022&S023_Cafergot_APPROVAL PACKAGE.pdf
10/31/2000 SUPPL-21 Labeling

Label is not available on this site.

10/31/2000 SUPPL-20 Labeling

Label is not available on this site.

07/14/1993 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

10/31/2000 SUPPL-17 Labeling

Label is not available on this site.

04/15/1993 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

10/31/2000 SUPPL-15 Labeling

Label is not available on this site.

03/04/1994 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/31/2000 SUPPL-13 Labeling

Label is not available on this site.

11/17/1988 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/10/1989 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

11/15/1988 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

07/25/1986 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

01/16/1985 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

07/15/1981 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/29/1981 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/06/1979 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/19/1979 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/04/2002 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/9000s22s23lbl.pdf
06/04/2002 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/9000s22s23lbl.pdf

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