NDA 010093

UCB INC

FDA Drug Application

Application #010093

Application Sponsors

NDA 010093

UCB INC

Marketing Status

• Discontinued: 003
• Discontinued: 007
• Discontinued: 009

Application Products

003	CAPSULE, EXTENDED RELEASE;ORAL	EQ 10MG BASE;EQ 10MG BASE	0	BIPHETAMINE 20	AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX
007	CAPSULE, EXTENDED RELEASE;ORAL	EQ 6.25MG BASE;EQ 6.25MG BASE	0	BIPHETAMINE 12.5	AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX
009	CAPSULE, EXTENDED RELEASE;ORAL	EQ 3.75MG BASE;EQ 3.75MG BASE	0	BIPHETAMINE 7.5	AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	1955-09-09	STANDARD
LABELING; Labeling	SUPPL	11	AP	1979-04-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1983-05-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	13	AP	1983-06-16	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	13	Null	0

CDER Filings

UCB INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 10093
            [companyName] => UCB INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BIPHETAMINE 12.5","activeIngredients":"AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX","strength":"EQ 6.25MG BASE;EQ 6.25MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BIPHETAMINE 20","activeIngredients":"AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX","strength":"EQ 10MG BASE;EQ 10MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"BIPHETAMINE 7.5","activeIngredients":"AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX","strength":"EQ 3.75MG BASE;EQ 3.75MG BASE","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"BIPHETAMINE 12.5","submission":"AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX","actionType":"EQ 6.25MG BASE;EQ 6.25MG BASE","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BIPHETAMINE 20","submission":"AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX","actionType":"EQ 10MG BASE;EQ 10MG BASE","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"BIPHETAMINE 7.5","submission":"AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX","actionType":"EQ 3.75MG BASE;EQ 3.75MG BASE","submissionClassification":"CAPSULE, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)