Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050689
Company: PFIZER
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MYCOBUTIN RIFABUTIN 150MG CAPSULE;ORAL Prescription AB Yes 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
12/23/1992 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/08/2021 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050689s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050689Orig1s025ltr.pdf
07/01/2015 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050689s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050689Orig1s022ltr.pdf
11/13/2014 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050689Orig1s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050689Orig1s018ltr.pdf
05/14/2008 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050689s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050689s016ltr.pdf
01/29/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

11/09/2001 SUPPL-13 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50689s13ltr.pdf
01/15/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/09/2001 SUPPL-11 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50689s11s13lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50689s13ltr.pdf
09/13/1996 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/03/1995 SUPPL-8 Labeling

Label is not available on this site.

01/11/1996 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/06/1994 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

05/31/1994 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

09/08/1995 SUPPL-4 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/22/1993 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

07/28/1993 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

07/26/1993 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/08/2021 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050689s025lbl.pdf
07/01/2015 SUPPL-22 Labeling-Package Insert Label (PDF) Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050689s022lbl.pdf
11/13/2014 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050689Orig1s018lbl.pdf
05/14/2008 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050689s016lbl.pdf
11/09/2001 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50689s11s13lbl.pdf

MYCOBUTIN

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 090033 LUPIN LTD

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