NDA 011613

UCB INC

FDA Drug Application

Application #011613

Documents

• Letter: 2003-10-16
• Letter: 2012-12-11
• Label: 2012-12-07

Application Sponsors

NDA 011613

UCB INC

Marketing Status

• Discontinued: 002
• Discontinued: 004

Application Products

002	CAPSULE, EXTENDED RELEASE;ORAL	EQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	0	IONAMIN	PHENTERMINE RESIN COMPLEX
004	CAPSULE, EXTENDED RELEASE;ORAL	EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	0	IONAMIN	PHENTERMINE RESIN COMPLEX

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1959-05-04	PRIORITY
LABELING; Labeling	SUPPL	6	AP	1975-04-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1978-10-31	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1980-05-02	PRIORITY
LABELING; Labeling	SUPPL	10	AP	1980-09-25
LABELING; Labeling	SUPPL	11	AP	1984-02-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1983-04-20	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1983-06-16	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1985-12-31	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1985-07-23	PRIORITY
LABELING; Labeling	SUPPL	17	AP	1985-09-04
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1987-05-04	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1987-07-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1987-08-03	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1993-07-08	PRIORITY
LABELING; Labeling	SUPPL	23	AP	1998-02-27	STANDARD
LABELING; Labeling	SUPPL	24	AP	1998-02-17	STANDARD
LABELING; Labeling	SUPPL	26	AP	2003-10-08	STANDARD
LABELING; Labeling	SUPPL	27	AP	2012-12-05	901 REQUIRED

Submissions Property Types

SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0
SUPPL	14	Null	0
SUPPL	15	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	27	Null	7

CDER Filings

UCB INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 11613
            [companyName] => UCB INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"IONAMIN","activeIngredients":"PHENTERMINE RESIN COMPLEX","strength":"EQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"IONAMIN","activeIngredients":"PHENTERMINE RESIN COMPLEX","strength":"EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/05\/2012","submission":"SUPPL-27","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/011613s027lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"IONAMIN","submission":"PHENTERMINE RESIN COMPLEX","actionType":"EQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"IONAMIN","submission":"PHENTERMINE RESIN COMPLEX","actionType":"EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 2012-12-05
        )

)