Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074803
Company: BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;ORAL Discontinued None No No
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;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
08/02/2001 ORIG-1 Approval Label (PDF)
Letter (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/74803_Fluoxetine_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/74803_Fluoxetine_Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/74803ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/074803_fluoxetine_toc.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/24/2010 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

07/14/2009 SUPPL-22 Labeling

Label is not available on this site.

09/25/2008 SUPPL-21 Labeling

Label is not available on this site.

03/17/2008 SUPPL-19 Labeling

Label is not available on this site.

03/17/2008 SUPPL-18 Labeling

Label is not available on this site.

08/25/2005 SUPPL-16 Labeling

Label is not available on this site.

08/25/2005 SUPPL-14 Labeling

Label is not available on this site.

11/26/2003 SUPPL-11 Labeling

Label is not available on this site.

11/26/2002 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

01/30/2002 SUPPL-9 Manufacturing (CMC)-Facility Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74803s4ltr.pdf
01/30/2002 SUPPL-8 Manufacturing (CMC)-Manufacturing Process Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74803s4ltr.pdf
01/30/2002 SUPPL-7 Manufacturing (CMC)-Facility Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74803s4ltr.pdf
01/30/2002 SUPPL-6 Manufacturing (CMC)-Packaging Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74803s4ltr.pdf
01/30/2002 SUPPL-5 Manufacturing (CMC)-Manufacturing Process Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74803s4ltr.pdf
01/30/2002 SUPPL-4 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/74803s4ltr.pdf
12/13/2001 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

12/13/2001 SUPPL-2 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

12/13/2001 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/02/2001 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/74803_Fluoxetine_Prntlbl.pdf

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