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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078572
Company: DR REDDYS LABS LTD
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
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
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-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels

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-Package Insert, Labeling-Medication Guide

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.

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