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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 004122
Company: LILLY
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SULFADIAZINE SULFADIAZINE 500MG TABLET;ORAL Discontinued None Yes 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
08/26/1941 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer 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
11/22/1985 SUPPL-8 Labeling

Label is not available on this site.

10/01/1986 SUPPL-6 Labeling

Label is not available on this site.

01/12/1978 SUPPL-5 Labeling

Label is not available on this site.

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