ANDA 090788

MYLAN PHARMS INC

FDA Drug Application

Application #090788

Documents

• Letter: 2010-04-13

Application Sponsors

ANDA 090788

MYLAN PHARMS INC

Marketing Status

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

Application Products

001	CAPSULE, DELAYED REL PELLETS;ORAL	125MG	0	DIDANOSINE	DIDANOSINE
002	CAPSULE, DELAYED REL PELLETS;ORAL	200MG	0	DIDANOSINE	DIDANOSINE
003	CAPSULE, DELAYED REL PELLETS;ORAL	250MG	0	DIDANOSINE	DIDANOSINE
004	CAPSULE, DELAYED REL PELLETS;ORAL	400MG	0	DIDANOSINE	DIDANOSINE

FDA Submissions

	ORIG	1	AP	2010-04-08
LABELING; Labeling	SUPPL	4	AP	2019-12-06	STANDARD
LABELING; Labeling	SUPPL	7	AP	2019-12-06	STANDARD
LABELING; Labeling	SUPPL	8	AP	2019-12-06	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	4	Null	15
SUPPL	7	Null	7
SUPPL	8	Null	15

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90788
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIDANOSINE","activeIngredients":"DIDANOSINE","strength":"125MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DIDANOSINE","activeIngredients":"DIDANOSINE","strength":"200MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DIDANOSINE","activeIngredients":"DIDANOSINE","strength":"250MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"DIDANOSINE","activeIngredients":"DIDANOSINE","strength":"400MG","dosageForm":"CAPSULE, DELAYED REL PELLETS;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DIDANOSINE","submission":"DIDANOSINE","actionType":"125MG","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DIDANOSINE","submission":"DIDANOSINE","actionType":"200MG","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DIDANOSINE","submission":"DIDANOSINE","actionType":"250MG","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"DIDANOSINE","submission":"DIDANOSINE","actionType":"400MG","submissionClassification":"CAPSULE, DELAYED REL PELLETS;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)