NDA 012302

ABBVIE

FDA Drug Application

Application #012302

Application Sponsors

NDA 012302

ABBVIE

Marketing Status

• Discontinued: 002
• Discontinued: 004
• Discontinued: 005
• Discontinued: 006

Application Products

002	TABLET;ORAL	2MG	0	CHOLOXIN	DEXTROTHYROXINE SODIUM
004	TABLET;ORAL	4MG	0	CHOLOXIN	DEXTROTHYROXINE SODIUM
005	TABLET;ORAL	1MG	0	CHOLOXIN	DEXTROTHYROXINE SODIUM
006	TABLET;ORAL	6MG	0	CHOLOXIN	DEXTROTHYROXINE SODIUM

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	1967-04-14	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	1975-10-03	PRIORITY
LABELING; Labeling	SUPPL	32	AP	1978-10-12	PRIORITY
LABELING; Labeling	SUPPL	39	AP	1980-09-17	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1982-04-13	PRIORITY
LABELING; Labeling	SUPPL	43	AP	1988-10-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	44	AP	1984-05-02	PRIORITY
LABELING; Labeling	SUPPL	45	AP	1989-04-20	PRIORITY

Submissions Property Types

ORIG	1	Null	0
SUPPL	28	Null	0
SUPPL	32	Null	0
SUPPL	39	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0
SUPPL	44	Null	0
SUPPL	45	Null	0

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 12302
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHOLOXIN","activeIngredients":"DEXTROTHYROXINE SODIUM","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CHOLOXIN","activeIngredients":"DEXTROTHYROXINE SODIUM","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CHOLOXIN","activeIngredients":"DEXTROTHYROXINE SODIUM","strength":"1MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CHOLOXIN","activeIngredients":"DEXTROTHYROXINE SODIUM","strength":"6MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CHOLOXIN","submission":"DEXTROTHYROXINE SODIUM","actionType":"2MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CHOLOXIN","submission":"DEXTROTHYROXINE SODIUM","actionType":"4MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CHOLOXIN","submission":"DEXTROTHYROXINE SODIUM","actionType":"1MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CHOLOXIN","submission":"DEXTROTHYROXINE SODIUM","actionType":"6MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)