NDA 012546

NOSTRUM LABS INC

FDA Drug Application

Application #012546

Documents

• Label: 2004-09-07
• Letter: 2004-09-07

Application Sponsors

NDA 012546

NOSTRUM LABS INC

Marketing Status

• Discontinued: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

75MG

1

TENUATE DOSPAN

DIETHYLPROPION HYDROCHLORIDE

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	1960-11-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1975-06-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1976-09-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1978-04-27	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1979-11-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1982-10-18	STANDARD
LABELING; Labeling	SUPPL	17	AP	1988-06-17
LABELING; Labeling	SUPPL	18	AP	1982-12-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1983-06-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1983-12-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1985-08-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1986-10-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1988-07-21	STANDARD
LABELING; Labeling	SUPPL	25	AP	1998-02-02
LABELING; Labeling	SUPPL	27	AP	1998-02-02	STANDARD
LABELING; Labeling	SUPPL	29	AP	1999-05-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2000-02-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	2002-04-16	STANDARD
LABELING; Labeling	SUPPL	32	AP	2004-09-03	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	33	AP	2013-12-19	STANDARD

Submissions Property Types

SUPPL	9	Null	0
SUPPL	11	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	24	Null	0
SUPPL	30	Null	0
SUPPL	31	Null	0
SUPPL	33	Null	0

CDER Filings

NOSTRUM LABS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 12546
            [companyName] => NOSTRUM LABS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"TENUATE DOSPAN","activeIngredients":"DIETHYLPROPION HYDROCHLORIDE","strength":"75MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"09\/03\/2004","submission":"SUPPL-32","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/11722s029,12546s032lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"TENUATE DOSPAN","submission":"DIETHYLPROPION HYDROCHLORIDE","actionType":"75MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2004-09-03
        )

)