Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040091
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SULFADIAZINE SULFADIAZINE 500MG TABLET;ORAL Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/29/1994 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
09/20/2002 SUPPL-8 Labeling

Label is not available on this site.

02/02/2000 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

06/17/1998 SUPPL-6 Labeling

Label is not available on this site.

07/21/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/21/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

10/08/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/09/1995 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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