ANDA 074962

UPSHER SMITH LABS

FDA Drug Application

Application #074962

Documents

• Letter: 1999-03-31
• Label: 2004-06-14
• Review: 2003-04-30

Application Sponsors

ANDA 074962

UPSHER SMITH LABS

Marketing Status

• Prescription: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

400MG

0

PENTOXIL

PENTOXIFYLLINE

FDA Submissions

	ORIG	1	AP	1999-03-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2000-04-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2002-12-19
LABELING; Labeling	SUPPL	5	AP	2004-10-29
LABELING; Labeling	SUPPL	8	AP	2005-08-30

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0

TE Codes

001

Prescription

AB

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 74962
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PENTOXIL","activeIngredients":"PENTOXIFYLLINE","strength":"400MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/31\/1999","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/99\\\/74-962_Pentoxifylline_prntlbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PENTOXIL","submission":"PENTOXIFYLLINE","actionType":"400MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1999-03-31
        )

)