Drugs@FDA: FDA-Approved Drugs

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

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