Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 064150
Company: SANDOZ
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RIFAMPIN RIFAMPIN 300MG CAPSULE;ORAL Prescription AB No No
RIFAMPIN RIFAMPIN 150MG CAPSULE;ORAL Prescription AB 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
05/28/1997 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/97/064150aplet.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/97/064150review.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/19/2013 SUPPL-20 Labeling-Package Insert

Label is not available on this site.

06/13/2011 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

09/06/2005 SUPPL-11 Labeling

Label is not available on this site.

06/28/2002 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/09/2000 SUPPL-6 Labeling

Label is not available on this site.

02/02/2000 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

03/03/1999 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/19/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/02/1998 SUPPL-2 Labeling

Label is not available on this site.

01/02/1998 SUPPL-1 Manufacturing (CMC)-New Strength

Label is not available on this site.

RIFAMPIN

CAPSULE;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RIFADIN RIFAMPIN 300MG CAPSULE;ORAL Prescription Yes AB 050420 SANOFI AVENTIS US
RIFAMPIN RIFAMPIN 300MG CAPSULE;ORAL Prescription No AB 065028 AKORN
RIFAMPIN RIFAMPIN 300MG CAPSULE;ORAL Prescription No AB 065390 LANNETT CO INC
RIFAMPIN RIFAMPIN 300MG CAPSULE;ORAL Prescription No AB 090034 LUPIN PHARMS
RIFAMPIN RIFAMPIN 300MG CAPSULE;ORAL Prescription No AB 064150 SANDOZ
RIMACTANE RIFAMPIN 300MG CAPSULE;ORAL Prescription No AB 050429 OXFORD PHARMS

CAPSULE;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
RIFADIN RIFAMPIN 150MG CAPSULE;ORAL Prescription No AB 062303 SANOFI AVENTIS US
RIFAMPIN RIFAMPIN 150MG CAPSULE;ORAL Prescription No AB 065028 AKORN
RIFAMPIN RIFAMPIN 150MG CAPSULE;ORAL Prescription No AB 065390 LANNETT CO INC
RIFAMPIN RIFAMPIN 150MG CAPSULE;ORAL Prescription No AB 090034 LUPIN PHARMS
RIFAMPIN RIFAMPIN 150MG CAPSULE;ORAL Prescription No AB 064150 SANDOZ

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