NDA 007935

DELCOR ASSET CORP

FDA Drug Application

Application #007935

Documents

• Letter: 2002-12-26
• Letter: 2002-12-26
• Letter: 2004-11-15
• Letter: 2002-12-26
• Label: 2004-11-15
• Other Important Information from FDA: 2006-04-26

Application Sponsors

NDA 007935

DELCOR ASSET CORP

Marketing Status

• Discontinued: 002
• Discontinued: 003
• Discontinued: 004

Application Products

002	TABLET;ORAL	12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	PHENERGAN	PROMETHAZINE HYDROCHLORIDE
003	TABLET;ORAL	25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	PHENERGAN	PROMETHAZINE HYDROCHLORIDE
004	TABLET;ORAL	50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	PHENERGAN	PROMETHAZINE HYDROCHLORIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1951-03-29	STANDARD
LABELING; Labeling	SUPPL	4	AP	2009-03-13
LABELING; Labeling	SUPPL	6	AP	2009-03-13
LABELING; Labeling	SUPPL	7	AP	2009-03-13
LABELING; Labeling	SUPPL	9	AP	2009-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1986-05-29	STANDARD
LABELING; Labeling	SUPPL	13	AP	2009-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1987-03-19	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1989-12-11	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1988-05-31	STANDARD
LABELING; Labeling	SUPPL	19	AP	1988-01-22
LABELING; Labeling	SUPPL	20	AP	1988-04-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1989-11-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1988-06-30	STANDARD
LABELING; Labeling	SUPPL	23	AP	2009-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1992-03-30	STANDARD
LABELING; Labeling	SUPPL	25	AP	2009-03-13	STANDARD
LABELING; Labeling	SUPPL	26	AP	2009-03-13	STANDARD
LABELING; Labeling	SUPPL	28	AP	2002-12-26	STANDARD
LABELING; Labeling	SUPPL	29	AP	2009-03-13	STANDARD
LABELING; Labeling	SUPPL	30	AP	2004-11-08	STANDARD

Submissions Property Types

SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	24	Null	0

CDER Filings

DELCOR ASSET CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 7935
            [companyName] => DELCOR ASSET CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"PHENERGAN","activeIngredients":"PROMETHAZINE HYDROCHLORIDE","strength":"12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"PHENERGAN","activeIngredients":"PROMETHAZINE HYDROCHLORIDE","strength":"25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"PHENERGAN","activeIngredients":"PROMETHAZINE HYDROCHLORIDE","strength":"50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"11\/08\/2004","submission":"SUPPL-30","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/07935s030lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"PHENERGAN","submission":"PROMETHAZINE HYDROCHLORIDE","actionType":"12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"PHENERGAN","submission":"PROMETHAZINE HYDROCHLORIDE","actionType":"25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"PHENERGAN","submission":"PROMETHAZINE HYDROCHLORIDE","actionType":"50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2004-11-08
        )

)