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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075755
Company: RISING

Other Important Information from FDA

Products on ANDA 075755

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET;ORAL	Discontinued	None	No	No
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 075755

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) Review		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75755_Prozac_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75755ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075755_fluoxetine_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2023	SUPPL-27	Labeling-Package Insert		Label is not available on this site.
09/20/2021	SUPPL-26	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/04/2017	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/14/2016	SUPPL-22	Labeling-Package Insert		Label is not available on this site.
11/17/2014	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/075755s021lbl.pdf
11/14/2014	SUPPL-19	Labeling-Package Insert		Label is not available on this site.
02/13/2009	SUPPL-17	Labeling		Label is not available on this site.
04/06/2009	SUPPL-16	Labeling		Label is not available on this site.
10/08/2008	SUPPL-15	Labeling		Label is not available on this site.
04/17/2008	SUPPL-14	Labeling		Label is not available on this site.
08/03/2007	SUPPL-13	Labeling		Label is not available on this site.
08/03/2007	SUPPL-12	Labeling		Label is not available on this site.
05/11/2005	SUPPL-10	Labeling		Label is not available on this site.
05/11/2005	SUPPL-8	Labeling		Label is not available on this site.
05/03/2002	SUPPL-1	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for ANDA 075755

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/17/2014	SUPPL-21	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/075755s021lbl.pdf
08/02/2001	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75755_Prozac_Prntlbl.pdf

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