Drug Master Files for SULBACTAM

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Drug Master Files can be found here.

FDA Approval Activities for this Drug…

Sulbactam - AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE; INJECTION EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL AMPICILLIN AND SULBACTAM ESI Lederle 065074 AP No AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE; INJECTION EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL AMPICILLIN AND SULBACTAM ESI Lederle 065074 AP No AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE; INJECTION EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL AMPICILLIN AND SULBACTAM ESI Lederle 050608 AP Yes AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE; INJECTION EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL UNASYN PFIZER 050608 AP Yes AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE; INJECTION EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL UNASYN PFIZER 062901 No AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE; INJECTION EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL UNASYN PFIZER 050608 AP Yes AMPICILLIN SODIUM; SULBACTAM SODIUM INJECTABLE; INJECTION EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL UNASYN PFIZER Unasyn (ampicillin sodium/sulbactam sodium) Injection, Pfizer, Labeling Revision

For the latest approval information, please see the main page.

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