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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065240
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE;INJECTION Prescription AP 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
07/25/2006 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
06/21/2021 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

05/14/2020 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

05/14/2020 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

03/01/2015 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

03/01/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

07/31/2013 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

10/31/2007 SUPPL-3 Manufacturing (CMC)-Microbiology-Processing

Label is not available on this site.

AMPICILLIN AND SULBACTAM

INJECTABLE;INJECTION; EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065403 ACS DOBFAR
AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090578 ASTRAL
AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090339 EUGIA PHARMA SPECLTS
AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065076 HIKMA
AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065188 HQ SPECLT PHARMA
AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065314 ISTITUTO BIO ITA SPA
AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202197 MYLAN LABS LTD
AMPICILLIN AND SULBACTAM AMPICILLIN SODIUM; SULBACTAM SODIUM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065240 SANDOZ
UNASYN AMPICILLIN SODIUM; SULBACTAM SODIUM EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL INJECTABLE;INJECTION Prescription Yes AP 050608 PFIZER
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