Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078572
Company: DR REDDYS LABS LTD

Products on ANDA 078572

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FLUOXETINE HYDROCHLORIDE	FLUOXETINE HYDROCHLORIDE	EQ 90MG BASE	CAPSULE, DELAYED REL PELLETS;ORAL	Prescription	None	No	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078572

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/22/2010	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078572s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/18/2023	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/20/2021	SUPPL-11	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert		Label is not available on this site.
09/01/2021	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/01/2021	SUPPL-8	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/01/2021	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/03/2014	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
11/03/2014	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/03/2014	SUPPL-4	Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/28/2012	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
11/22/2011	SUPPL-2	Labeling-Package Insert		Label is not available on this site.