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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 062692
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 125MG BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 250MG BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 500MG BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 1GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 2GM BASE/VIAL INJECTABLE;INJECTION Discontinued None No No
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION 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
06/24/1986 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
08/16/2019 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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