ANDA 091294

MYLAN PHARMS INC

FDA Drug Application

Application #091294

Documents

• Letter: 2012-06-20
• Review: 2020-03-19

Application Sponsors

ANDA 091294

MYLAN PHARMS INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 300MG BASE

0

ABACAVIR SULFATE

ABACAVIR SULFATE

FDA Submissions

	ORIG	1	AP	2012-06-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2015-12-11	UNKNOWN
LABELING; Labeling	SUPPL	4	AP	2015-12-11	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	7

TE Codes

001

Prescription

AB

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91294
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ABACAVIR SULFATE","activeIngredients":"ABACAVIR SULFATE","strength":"EQ 300MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ABACAVIR SULFATE","submission":"ABACAVIR SULFATE","actionType":"EQ 300MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)