ANDA 091189

MAYNE PHARMA INC

FDA Drug Application

Application #091189

Application Sponsors

ANDA 091189

MAYNE PHARMA INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

5MG

0

METHAMPHETAMINE HYDROCHLORIDE

METHAMPHETAMINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2010-04-21
LABELING; Labeling	SUPPL	2	AP	2016-09-02	STANDARD
LABELING; Labeling	SUPPL	3	AP	2016-09-02	STANDARD
LABELING; Labeling	SUPPL	4	AP	2019-11-14	STANDARD
LABELING; Labeling	SUPPL	5	AP	2019-11-14	STANDARD
LABELING; Labeling	SUPPL	6	AP	2019-11-14	STANDARD

Submissions Property Types

ORIG	1	Null	3
SUPPL	2	Null	15
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	15
SUPPL	6	Null	15

TE Codes

001

Prescription

AA

CDER Filings

MAYNE PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91189
            [companyName] => MAYNE PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHAMPHETAMINE HYDROCHLORIDE","activeIngredients":"METHAMPHETAMINE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"METHAMPHETAMINE HYDROCHLORIDE","submission":"METHAMPHETAMINE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)