Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 061392
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRINCIPEN AMPICILLIN/AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE;ORAL Discontinued None No No
PRINCIPEN 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
03/03/1971 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
02/20/2002 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/11/1997 SUPPL-2 Labeling

Label is not available on this site.

02/29/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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