Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 062303
Company: SANOFI AVENTIS US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RIFADIN 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
07/15/1981 ORIG-1 Approval UNKNOWN

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/23/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

08/18/1994 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

10/23/1995 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

07/24/1992 SUPPL-3 Labeling

Label is not available on this site.

07/24/1992 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/28/1995 SUPPL-1 Labeling Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.

Label is not available on this site.

RIFADIN

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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