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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209253
Company: ACTAVIS LABS FL INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMPHETAMINE AMPHETAMINE EQ 3.1MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Discontinued None No No
AMPHETAMINE AMPHETAMINE EQ 6.3MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Discontinued None No No
AMPHETAMINE AMPHETAMINE EQ 9.4MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Discontinued None No No
AMPHETAMINE AMPHETAMINE EQ 12.5MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Discontinued None No No
AMPHETAMINE AMPHETAMINE EQ 15.7MG BASE TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Discontinued None No No
AMPHETAMINE AMPHETAMINE EQ 18.8MG BASE TABLET, ORALLY DISINTEGRATING, 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
06/22/2023 ORIG-1 Approval STANDARD Letter (PDF)

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 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209253Orig1s000ltr.pdf
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