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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 061502
Company: HERITAGE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMPICILLIN TRIHYDRATE AMPICILLIN/AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE;ORAL Discontinued None No No
AMPICILLIN TRIHYDRATE AMPICILLIN/AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE;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
11/09/1971 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
07/07/2000 SUPPL-137 Manufacturing (CMC)-Facility

Label is not available on this site.

12/10/1997 SUPPL-136 Manufacturing (CMC)

Label is not available on this site.

08/27/1996 SUPPL-135 Manufacturing (CMC)

Label is not available on this site.

11/05/1991 SUPPL-134 Labeling

Label is not available on this site.

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