NDA 018066

CHATTEM

FDA Drug Application

Application #018066

Documents

• Letter: 2002-05-30
• Letter: 2002-05-30
• Letter: 2013-09-13
• Label: 2013-09-24
• Letter: 2022-12-02
• Label: 2022-12-05

Application Sponsors

NDA 018066

CHATTEM

Marketing Status

• Over-the-counter: 001

Application Products

001

TABLET;ORAL

25MG

1

UNISOM

DOXYLAMINE SUCCINATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1978-10-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1981-08-31	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1981-12-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1982-08-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1982-08-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1987-08-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1983-03-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1984-02-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1989-05-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1984-08-24	STANDARD
LABELING; Labeling	SUPPL	11	AP	2002-05-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2002-04-26	STANDARD
LABELING; Labeling	SUPPL	13	AP	2002-05-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	2002-12-20	STANDARD
LABELING; Labeling	SUPPL	20	AP	2013-09-12	STANDARD
LABELING; Labeling	SUPPL	21	AP	2022-12-01	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	20	Null	7
SUPPL	21	Null	6

CDER Filings

CHATTEM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18066
            [companyName] => CHATTEM
            [docInserts] => ["",""]
            [products] => [{"drugName":"UNISOM","activeIngredients":"DOXYLAMINE SUCCINATE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Over-the-counter","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"09\/12\/2013","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/018066Orig1s020lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"UNISOM","submission":"DOXYLAMINE SUCCINATE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Over-the-counter","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2013-09-12
        )

)