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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200151
Company: TEVA PHARMS USA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SELFEMRA FLUOXETINE HYDROCHLORIDE EQ 10MG BASE TABLET;ORAL Discontinued None No No
SELFEMRA FLUOXETINE HYDROCHLORIDE EQ 15MG BASE TABLET;ORAL Discontinued None No No
SELFEMRA FLUOXETINE HYDROCHLORIDE EQ 20MG BASE TABLET;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
02/03/2014 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/21/2021 SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/20/2020 SUPPL-4 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/04/2017 SUPPL-3 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/21/2016 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/18/2014 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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