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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074803
Company: BARR

Other Important Information from FDA

Products on ANDA 074803

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 074803

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.

Labels for ANDA 074803

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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