ANDA 091220

MICRO LABS

FDA Drug Application

Application #091220

Application Sponsors

ANDA 091220

MICRO LABS

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005
• Prescription: 006

Application Products

001	TABLET;ORAL	1MG	0	GLIMEPIRIDE	GLIMEPIRIDE
002	TABLET;ORAL	2MG	0	GLIMEPIRIDE	GLIMEPIRIDE
003	TABLET;ORAL	3MG	0	GLIMEPIRIDE	GLIMEPIRIDE
004	TABLET;ORAL	4MG	0	GLIMEPIRIDE	GLIMEPIRIDE
005	TABLET;ORAL	6MG	0	GLIMEPIRIDE	GLIMEPIRIDE
006	TABLET;ORAL	8MG	0	GLIMEPIRIDE	GLIMEPIRIDE

FDA Submissions

	ORIG	1	AP	2012-06-29
LABELING; Labeling	SUPPL	2	AP	2014-12-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2014-12-03
LABELING; Labeling	SUPPL	10	AP	2017-08-25	STANDARD
LABELING; Labeling	SUPPL	14	AP	2020-04-07	STANDARD
LABELING; Labeling	SUPPL	15	AP	2020-09-15	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	10	Null	7
SUPPL	14	Null	7
SUPPL	15	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
004	Prescription	AB
006	Prescription	AB

CDER Filings

MICRO LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91220
            [companyName] => MICRO LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLIMEPIRIDE","activeIngredients":"GLIMEPIRIDE","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GLIMEPIRIDE","activeIngredients":"GLIMEPIRIDE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GLIMEPIRIDE","activeIngredients":"GLIMEPIRIDE","strength":"3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"GLIMEPIRIDE","activeIngredients":"GLIMEPIRIDE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"GLIMEPIRIDE","activeIngredients":"GLIMEPIRIDE","strength":"6MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"GLIMEPIRIDE","activeIngredients":"GLIMEPIRIDE","strength":"8MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GLIMEPIRIDE","submission":"GLIMEPIRIDE","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GLIMEPIRIDE","submission":"GLIMEPIRIDE","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GLIMEPIRIDE","submission":"GLIMEPIRIDE","actionType":"3MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GLIMEPIRIDE","submission":"GLIMEPIRIDE","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GLIMEPIRIDE","submission":"GLIMEPIRIDE","actionType":"6MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"GLIMEPIRIDE","submission":"GLIMEPIRIDE","actionType":"8MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)