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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 080120
Company: WHITEWORTH TOWN PLSN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ISONIAZID ISONIAZID 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
04/14/1971 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
12/04/1985 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

12/04/1985 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

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