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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215041
Company: NOVITIUM PHARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RIFABUTIN RIFABUTIN 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
12/17/2021 ORIG-1 Approval STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/10/2025 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

RIFABUTIN

CAPSULE;ORAL; 150MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MYCOBUTIN RIFABUTIN 150MG CAPSULE;ORAL Prescription Yes AB 050689 PFIZER
RIFABUTIN RIFABUTIN 150MG CAPSULE;ORAL Prescription No AB 212430 I3 PHARMS
RIFABUTIN RIFABUTIN 150MG CAPSULE;ORAL Prescription No AB 215041 NOVITIUM PHARMA
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