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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075292
Company: NOSTRUM LABS INC
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/07/2002 ORIG-1 Approval Letter (PDF)
Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75292TA.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75292ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/20/2021 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

09/12/2021 SUPPL-20 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

01/04/2017 SUPPL-19 Labeling-Package Insert

Label is not available on this site.

09/02/2014 SUPPL-18 Labeling-Package Insert

Label is not available on this site.

05/29/2012 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

12/02/2008 SUPPL-15 Labeling

Label is not available on this site.

06/29/2007 SUPPL-12 Labeling

Label is not available on this site.

06/29/2007 SUPPL-11 Labeling

Label is not available on this site.

08/29/2006 SUPPL-10 Labeling

Label is not available on this site.

08/29/2006 SUPPL-9 Labeling

Label is not available on this site.

03/15/2006 SUPPL-7 Labeling

Label is not available on this site.

05/17/2005 SUPPL-5 Labeling

Label is not available on this site.

05/17/2005 SUPPL-4 Labeling

Label is not available on this site.

09/03/2002 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

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