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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064082
Company: SANDOZ
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 Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/29/1995 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
12/22/2020 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

09/30/2004 SUPPL-8 Labeling

Label is not available on this site.

04/07/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/04/1996 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

11/04/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/04/1996 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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