NDA 007638

BAYER HEALTHCARE LLC

FDA Drug Application

Application #007638

Documents

• Letter: 2006-01-30
• Letter: 2008-02-07
• Letter: 2015-12-29

Application Sponsors

NDA 007638

BAYER HEALTHCARE LLC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	8MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	CHLOR-TRIMETON	CHLORPHENIRAMINE MALEATE
002	TABLET, EXTENDED RELEASE;ORAL	12MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	CHLOR-TRIMETON	CHLORPHENIRAMINE MALEATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1950-08-15	STANDARD
LABELING; Labeling	SUPPL	2	AP	1978-10-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1979-01-05	STANDARD
LABELING; Labeling	SUPPL	7	AP	1979-12-20
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1980-02-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1980-07-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1980-07-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1980-06-11	STANDARD
LABELING; Labeling	SUPPL	12	AP	1981-10-30
EFFICACY; Efficacy	SUPPL	13	AP	1982-05-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1982-08-30	STANDARD
LABELING; Labeling	SUPPL	16	AP	1983-01-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1983-02-18	STANDARD
LABELING; Labeling	SUPPL	18	AP	1986-01-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1984-09-18	STANDARD
EFFICACY; Efficacy	SUPPL	22	AP	1986-01-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1986-07-08	STANDARD
LABELING; Labeling	SUPPL	24	AP	1997-10-20	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1998-11-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2000-05-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	28	AP	2001-01-26	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2002-03-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2006-01-19	STANDARD
LABELING; Labeling	SUPPL	33	AP	2008-02-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	38	AP	2015-12-23	N/A

Submissions Property Types

SUPPL	6	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	15	Null	0
SUPPL	17	Null	0
SUPPL	21	Null	0
SUPPL	23	Null	0
SUPPL	25	Null	0
SUPPL	27	Null	0
SUPPL	28	Null	0
SUPPL	29	Null	0
SUPPL	32	Null	0
SUPPL	38	Null	7

CDER Filings

BAYER HEALTHCARE LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 7638
            [companyName] => BAYER HEALTHCARE LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CHLOR-TRIMETON","activeIngredients":"CHLORPHENIRAMINE MALEATE","strength":"8MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"CHLOR-TRIMETON","activeIngredients":"CHLORPHENIRAMINE MALEATE","strength":"12MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CHLOR-TRIMETON","submission":"CHLORPHENIRAMINE MALEATE","actionType":"8MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"CHLOR-TRIMETON","submission":"CHLORPHENIRAMINE MALEATE","actionType":"12MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)