NDA 050689

PHARMACIA AND UPJOHN

FDA Drug Application

Application #050689

Documents

• Letter: 2001-11-09
• Letter: 2015-07-09
• Label: 2008-06-05
• Letter: 2001-11-09
• Letter: 2008-05-14
• Letter: 2014-11-14
• Label: 2003-05-07
• Label: 2014-12-02
• Label: 2015-07-06
• Letter: 2021-03-09
• Label: 2021-03-09
• Letter: 2021-09-17
• Label: 2021-09-20

Application Sponsors

NDA 050689

PHARMACIA AND UPJOHN

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

150MG

1

MYCOBUTIN

RIFABUTIN

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1992-12-23	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1993-07-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1993-06-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1995-09-08
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1994-05-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1994-06-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1996-01-11
LABELING; Labeling	SUPPL	8	AP	1995-11-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1996-09-13
LABELING; Labeling	SUPPL	11	AP	2001-11-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1999-01-15
LABELING; Labeling	SUPPL	13	AP	2001-11-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2001-01-29
LABELING; Labeling	SUPPL	16	AP	2008-05-14	STANDARD
LABELING; Labeling	SUPPL	18	AP	2014-11-13	STANDARD
LABELING; Labeling	SUPPL	22	AP	2015-07-01	STANDARD Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.
LABELING; Labeling	SUPPL	25	AP	2021-03-08	STANDARD
LABELING; Labeling	SUPPL	26	AP	2021-09-15	STANDARD

Submissions Property Types

ORIG	1	Null	39
SUPPL	2	Null	14
SUPPL	3	Null	14
SUPPL	4	Null	14
SUPPL	5	Null	14
SUPPL	6	Null	14
SUPPL	7	Null	14
SUPPL	10	Null	14
SUPPL	12	Null	14
SUPPL	14	Null	14
SUPPL	16	Null	4
SUPPL	18	Null	15
SUPPL	22	Null	6
SUPPL	25	Null	6
SUPPL	26	Null	6

TE Codes

001

Prescription

AB

CDER Filings

PFIZER

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(
    [0] => Array
        (
            [ApplNo] => 50689
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"MYCOBUTIN","activeIngredients":"RIFABUTIN","strength":"150MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/15\/2021","submission":"SUPPL-26","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/050689s026lbl.pdf\"}]","notes":""},{"actionDate":"03\/08\/2021","submission":"SUPPL-25","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/050689s025lbl.pdf\"}]","notes":""},{"actionDate":"07\/01\/2015","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/050689s022lbl.pdf\"}]","notes":"Please see"},{"actionDate":"11\/13\/2014","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/050689Orig1s018lbl.pdf\"}]","notes":""},{"actionDate":"05\/14\/2008","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/050689s016lbl.pdf\"}]","notes":""},{"actionDate":"11\/09\/2001","submission":"SUPPL-11","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2001\\\/50689s11s13lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"MYCOBUTIN","submission":"RIFABUTIN","actionType":"150MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2021-09-15
        )

)