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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050689
Company: PFIZER

Products on NDA 050689

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MYCOBUTIN	RIFABUTIN	150MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050689

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
09/15/2021	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050689s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/050689Orig1s026ltr.pdf
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.

Labels for NDA 050689

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/15/2021	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/050689s026lbl.pdf
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

Therapeutic Equivalents for NDA 050689

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
RIFABUTIN	RIFABUTIN	150MG	CAPSULE;ORAL	Prescription	No	AB	215041	NOVITIUM PHARMA

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