Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076458
Company: CHARTWELL MOLECULAR

• Other Important Information from FDA

Products on ANDA 076458

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 20MG BASE/5ML	SOLUTION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076458

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/14/2004	ORIG-1	Approval			Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076458_S000_FLUOXETINETOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/13/2025	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/18/2023	SUPPL-11	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
09/21/2021	SUPPL-10	Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Medication Guide		Label is not available on this site.
01/04/2017	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/12/2015	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
09/28/2009	SUPPL-6	Labeling		Label is not available on this site.
08/18/2008	SUPPL-5	Labeling		Label is not available on this site.
02/14/2008	SUPPL-4	Labeling		Label is not available on this site.
08/02/2007	SUPPL-3	Labeling		Label is not available on this site.
08/02/2007	SUPPL-2	Labeling		Label is not available on this site.
09/15/2005	SUPPL-1	Labeling		Label is not available on this site.