Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 075920
Company: SPECGX LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION;ORAL Prescription AA 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

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/04/2017 SUPPL-16 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/17/2014 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

09/28/2009 SUPPL-14 Labeling

Label is not available on this site.

09/24/2008 SUPPL-13 Labeling

Label is not available on this site.

03/03/2008 SUPPL-12 Labeling

Label is not available on this site.

06/29/2007 SUPPL-11 Labeling

Label is not available on this site.

06/29/2007 SUPPL-10 Labeling

Label is not available on this site.

09/27/2006 SUPPL-9 Labeling

Label is not available on this site.

02/28/2006 SUPPL-8 Labeling

Label is not available on this site.

02/28/2006 SUPPL-7 Labeling

Label is not available on this site.

10/21/2005 SUPPL-6 Labeling

Label is not available on this site.

12/06/2004 SUPPL-4 Labeling

Label is not available on this site.

12/06/2004 SUPPL-2 Labeling

Label is not available on this site.

11/13/2003 SUPPL-1 Labeling

Label is not available on this site.

FLUOXETINE HYDROCHLORIDE

SOLUTION;ORAL; EQ 20MG BASE/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION;ORAL Prescription No AA 077849 LANNETT CO INC
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION;ORAL Prescription No AA 076015 PHARM ASSOC
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION;ORAL Prescription No AA 075920 SPECGX LLC
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION;ORAL Prescription No AA 075506 TEVA
FLUOXETINE HYDROCHLORIDE FLUOXETINE HYDROCHLORIDE EQ 20MG BASE/5ML SOLUTION;ORAL Prescription No AA 075514 WOCKHARDT BIO AG

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