Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 061370
Company: TEVA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMPICILLIN TRIHYDRATE AMPICILLIN/AMPICILLIN TRIHYDRATE EQ 125MG BASE/5ML FOR SUSPENSION;ORAL Discontinued None No No
AMPICILLIN TRIHYDRATE 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
08/03/1971 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
12/22/1997 SUPPL-91 Manufacturing (CMC)

Label is not available on this site.

08/28/1996 SUPPL-90 Manufacturing (CMC)

Label is not available on this site.

12/22/1994 SUPPL-89 Manufacturing (CMC)

Label is not available on this site.

11/25/1991 SUPPL-88 Labeling

Label is not available on this site.

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