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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065188
Company: HQ SPECLT PHARMA
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
11/25/2005 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
11/16/2019 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

06/01/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

06/01/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

07/28/2020 SUPPL-10 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

06/28/2013 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

08/05/2008 SUPPL-3 Labeling

Label is not available on this site.

07/17/2007 SUPPL-2 Labeling

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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