Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086562
Company: ORGANON USA INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
WIGRAINE CAFFEINE; ERGOTAMINE TARTRATE 100MG;1MG TABLET;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
11/05/1980 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/02/2000 SUPPL-17 Manufacturing (CMC)-Facility

Label is not available on this site.

10/14/1999 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/21/1998 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/07/1994 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/31/1993 SUPPL-13 Labeling

Label is not available on this site.

08/31/1993 SUPPL-12 Labeling

Label is not available on this site.

03/07/1994 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/12/1998 SUPPL-10 Labeling

Label is not available on this site.

01/19/1989 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/06/1987 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/14/1985 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/29/1983 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/29/1983 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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