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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 064217
Company: HIKMA

Products on ANDA 064217

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RIFAMPIN	RIFAMPIN	600MG/VIAL	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 064217

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.

Labels for ANDA 064217

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

Therapeutic Equivalents for ANDA 064217

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	EPIC PHARMA LLC
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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