Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090889
Company: ACS DOBFAR SPA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 10GM 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
04/03/2013 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
04/03/2019 SUPPL-2 Labeling-Package Insert

Label is not available on this site.
04/03/2019 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

AMPICILLIN SODIUM

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090889 ACS DOBFAR SPA
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 065493 AUROBINDO PHARMA
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 063142 HQ SPECLT PHARMA
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 201404 ISTITUTO BIO ITA SPA
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 202198 MYLAN LABS LTD
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 090581 SAGENT PHARMS INC
AMPICILLIN SODIUM AMPICILLIN SODIUM EQ 10GM BASE/VIAL INJECTABLE;INJECTION Prescription No AP 061395 SANDOZ

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