Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087318
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOLBUTAMIDE TOLBUTAMIDE 500MG 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
03/31/1981 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
08/08/1991 SUPPL-22 Labeling

Label is not available on this site.

07/10/1991 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

07/10/1991 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

01/28/1991 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

08/07/1991 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/06/1988 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

05/06/1988 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

05/02/1985 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

05/02/1985 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/08/1984 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

02/17/1984 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/17/1984 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

02/17/1984 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/16/1982 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

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