Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 061394
Company: APOTHECON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRINCIPEN AMPICILLIN/AMPICILLIN TRIHYDRATE EQ 100MG BASE/ML FOR SUSPENSION;ORAL Discontinued None No No
PRINCIPEN AMPICILLIN/AMPICILLIN TRIHYDRATE EQ 125MG BASE/5ML FOR SUSPENSION;ORAL Discontinued None No No
PRINCIPEN AMPICILLIN/AMPICILLIN TRIHYDRATE EQ 250MG BASE/5ML FOR SUSPENSION;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
06/30/1998 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

07/11/1997 SUPPL-27 Labeling

Label is not available on this site.

02/29/1996 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

02/03/1992 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

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