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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 065421
Company: MYLAN LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RIFAMPIN RIFAMPIN 600MG/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
05/22/2008 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
07/01/2020 SUPPL-14 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

07/01/2020 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

07/01/2020 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

10/27/2015 SUPPL-3 Labeling-Package Insert, Labeling-Package Insert

Label is not available on this site.

RIFAMPIN

INJECTABLE;INJECTION; 600MG/VIAL
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RIFADIN RIFAMPIN 600MG/VIAL INJECTABLE;INJECTION Prescription Yes AP 050627 SANOFI AVENTIS US
RIFAMPIN RIFAMPIN 600MG/VIAL INJECTABLE;INJECTION Prescription No AP 065502 AKORN
RIFAMPIN RIFAMPIN 600MG/VIAL INJECTABLE;INJECTION Prescription No AP 091181 FRESENIUS KABI USA
RIFAMPIN RIFAMPIN 600MG/VIAL INJECTABLE;INJECTION Prescription No AP 064217 HIKMA
RIFAMPIN RIFAMPIN 600MG/VIAL INJECTABLE;INJECTION Prescription No AP 205039 HIKMA PHARMS
RIFAMPIN RIFAMPIN 600MG/VIAL INJECTABLE;INJECTION Prescription No AP 065421 MYLAN LABS LTD
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