Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075577
Company: MYLAN PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 10MG BASE CAPSULE;ORAL Discontinued None No No
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE CAPSULE;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
01/29/2002 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75577TA.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/06/2009 SUPPL-11 Labeling

Label is not available on this site.

10/08/2008 SUPPL-10 Labeling

Label is not available on this site.

04/17/2008 SUPPL-9 Labeling

Label is not available on this site.

09/12/2007 SUPPL-8 Labeling

Label is not available on this site.

09/12/2007 SUPPL-7 Labeling

Label is not available on this site.

02/28/2006 SUPPL-6 Labeling

Label is not available on this site.

05/17/2005 SUPPL-4 Labeling

Label is not available on this site.

05/17/2005 SUPPL-3 Labeling

Label is not available on this site.

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