Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 010093
Company: UCB INC

Products on NDA 010093

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BIPHETAMINE 12.5	AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX	EQ 6.25MG BASE;EQ 6.25MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
BIPHETAMINE 20	AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX	EQ 10MG BASE;EQ 10MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No
BIPHETAMINE 7.5	AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX	EQ 3.75MG BASE;EQ 3.75MG BASE	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 010093

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/09/1955	ORIG-1	Approval	Type 2 - New Active Ingredient	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/16/1983	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
05/06/1983	SUPPL-12	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/04/1979	SUPPL-11	Labeling		Label is not available on this site.