Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090034
Company: LUPIN PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RIFAMPIN RIFAMPIN 150MG CAPSULE;ORAL Prescription AB No No
RIFAMPIN RIFAMPIN 300MG CAPSULE;ORAL Prescription AB No Yes

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/21/2013 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
08/17/2020 SUPPL-13 Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.
03/31/2020 SUPPL-12 Labeling-Package Insert

Label is not available on this site.
03/31/2020 SUPPL-11 Labeling-Package Insert

Label is not available on this site.
03/31/2020 SUPPL-10 Labeling-Package Insert

Label is not available on this site.
03/31/2020 SUPPL-9 Labeling-Package Insert

Label is not available on this site.
03/31/2020 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

RIFAMPIN

CAPSULE;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
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

CAPSULE;ORAL; 300MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
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

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