Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 064217
Company: WEST-WARD PHARMS INT
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
10/29/1999 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/64-217_Rifampin_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/64217LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/64-217_Rifampin.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/13/2011 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

01/29/2001 SUPPL-2 Labeling

Label is not available on this site.

09/29/2000 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/29/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/64-217_Rifampin_prntlbl.pdf

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 204101 EMCURE PHARMS LTD
RIFAMPIN RIFAMPIN 600MG/VIAL INJECTABLE;INJECTION Prescription No AP 091181 FRESENIUS KABI USA
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
RIFAMPIN RIFAMPIN 600MG/VIAL INJECTABLE;INJECTION Prescription No AP 206736 WATSON PHARMS TEVA
RIFAMPIN RIFAMPIN 600MG/VIAL INJECTABLE;INJECTION Prescription No AP 064217 WEST-WARD PHARMS INT

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