NDA 021453

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #021453

Documents

• Letter: 2002-12-31
• Letter: 2004-06-07
• Review: 2006-06-08
• Letter: 2005-01-21
• Label: 2003-04-09
• Label: 2004-06-07
• Label: 2005-01-21

Application Sponsors

NDA 021453

BRISTOL MYERS SQUIBB

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004

Application Products

001	CAPSULE, EXTENDED RELEASE;ORAL	37.5MG	0	ZERIT XR	STAVUDINE
002	CAPSULE, EXTENDED RELEASE;ORAL	50MG	0	ZERIT XR	STAVUDINE
003	CAPSULE, EXTENDED RELEASE;ORAL	75MG	0	ZERIT XR	STAVUDINE
004	CAPSULE, EXTENDED RELEASE;ORAL	100MG	0	ZERIT XR	STAVUDINE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2002-12-31	STANDARD
LABELING; Labeling	SUPPL	3	AP	2004-06-04	STANDARD
LABELING; Labeling	SUPPL	4	AP	2005-01-19	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0

CDER Filings

BRISTOL MYERS SQUIBB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21453
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZERIT XR","activeIngredients":"STAVUDINE","strength":"37.5MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ZERIT XR","activeIngredients":"STAVUDINE","strength":"50MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ZERIT XR","activeIngredients":"STAVUDINE","strength":"75MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"ZERIT XR","activeIngredients":"STAVUDINE","strength":"100MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/19\/2005","submission":"SUPPL-4","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/21453s004lbl.pdf\"}]","notes":""},{"actionDate":"06\/04\/2004","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/21453slr003_zerit_lbl.pdf\"}]","notes":""},{"actionDate":"12\/31\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21453_Zerit_lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ZERIT XR","submission":"STAVUDINE","actionType":"37.5MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ZERIT XR","submission":"STAVUDINE","actionType":"50MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ZERIT XR","submission":"STAVUDINE","actionType":"75MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"ZERIT XR","submission":"STAVUDINE","actionType":"100MG","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2005-01-19
        )

)