Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012715
Company: ROCHE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GANTANOL SULFAMETHOXAZOLE 500MG TABLET;ORAL Discontinued None No No
GANTANOL-DS SULFAMETHOXAZOLE 1GM 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
08/25/1965 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/17/2001 SUPPL-29 Labeling

Label is not available on this site.

09/17/2001 SUPPL-27 Labeling

Label is not available on this site.

09/17/2001 SUPPL-25 Labeling

Label is not available on this site.

05/04/1978 SUPPL-24 Labeling

Label is not available on this site.

01/05/1978 SUPPL-20 Labeling

Label is not available on this site.

05/04/1977 SUPPL-19 Labeling

Label is not available on this site.

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