ANDA 090097

MAYNE PHARMA INC

FDA Drug Application

Application #090097

Documents

• Review: 2011-12-09

Application Sponsors

ANDA 090097

MAYNE PHARMA INC

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	EQ 0.005MG BASE	0	LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM
002	TABLET;ORAL	EQ 0.025MG BASE	0	LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM
003	TABLET;ORAL	EQ 0.05MG BASE	0	LIOTHYRONINE SODIUM	LIOTHYRONINE SODIUM

FDA Submissions

	ORIG	1	AP	2009-03-20
LABELING; Labeling	SUPPL	13	AP	2019-12-17	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	13	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

MAYNE PHARMA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90097
            [companyName] => MAYNE PHARMA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LIOTHYRONINE SODIUM","activeIngredients":"LIOTHYRONINE SODIUM","strength":"EQ 0.005MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LIOTHYRONINE SODIUM","activeIngredients":"LIOTHYRONINE SODIUM","strength":"EQ 0.025MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LIOTHYRONINE SODIUM","activeIngredients":"LIOTHYRONINE SODIUM","strength":"EQ 0.05MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"LIOTHYRONINE SODIUM","submission":"LIOTHYRONINE SODIUM","actionType":"EQ 0.005MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LIOTHYRONINE SODIUM","submission":"LIOTHYRONINE SODIUM","actionType":"EQ 0.025MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"LIOTHYRONINE SODIUM","submission":"LIOTHYRONINE SODIUM","actionType":"EQ 0.05MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)