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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 070159
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TOLAZAMIDE TOLAZAMIDE 100MG 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
01/06/1986 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
07/08/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/21/1992 SUPPL-10 Labeling

Label is not available on this site.

02/19/1992 SUPPL-9 Labeling

Label is not available on this site.

02/13/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/30/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/30/1986 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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