Major Depressive Disorder

• FDA label_change · 2016-01-10
  FDA Approved: FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for fluoxetine from Teva Pharmaceuticals USA, Inc. to update the product labeling.

• FDA label_change · 2015-12-30
  FDA Approved: REMERONSOLTAB — Supplemental Application (Organon LLC)

  FDA approved a supplemental application for REMERON SolTab (mirtazapine) from Organon LLC, resulting in a labeling change.

• FDA label_change · 2015-12-16
  FDA Approved: VIIBRYD — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for Viibryd (vilazodone hydrochloride) from Allergan, Inc., indicating changes to the product labeli…

• FDA label_change · 2015-10-19
  FDA Approved: ESCITALOPRAM OXALATE — Supplemental Application (Exelan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Escitalopram Oxalate by Exelan Pharmaceuticals, indicating a change to the drug's labeling under…

• FDA label_change · 2014-11-06
  FDA Approved: QUETIAPINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for quetiapine by Teva Pharmaceuticals USA, Inc., resulting in labeling updates for the product. The…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA label_change · 2014-07-18
  FDA Approved: VENLAFAXINE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for Venlafaxine from BluePoint Laboratories. The update concerns this generic product's regulatory s…

• FDA label_change · 2014-07-17
  FDA Approved: TRAZODONE HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for trazodone hydrochloride from Sun Pharmaceutical Industries, resulting in changes to the drug…

• FDA label_change · 2014-04-16
  FDA Approved: CELEXA — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for Celexa (citalopram) by Allergan, Inc., for a label update.

• FDA label_change · 2013-02-01
  FDA Approved: SERTRALINE HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA supplemental approval for sertraline hydrochloride from Mylan to update labeling.

• FDA label_change · 2012-12-21
  FDA Approved: VIIBRYD — Supplemental Application (Allergan, Inc.)

  The FDA approved Allergan's supplemental application for VIIBRYD (vilazodone hydrochloride). The action is related to updates to the drug's …

• FDA label_change · 2011-09-21
  FDA Approved: VIIBRYD — Supplemental Application (Allergan, Inc.)

  The FDA approved a supplemental application for VIIBRYD (vilazodone hydrochloride) from Allergan, Inc., updating the product labeling.

• FDA label_change · 2011-06-29
  FDA Approved: VIIBRYD — Supplemental Application (Allergan, Inc.)

  FDA records a supplemental application for VIIBRYD (vilazodone hydrochloride) filed by Allergan, Inc., likely seeking changes to the labelin…

• FDA label_change · 2010-12-30
  FDA Approved: NORTRIPTYLINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Nortriptyline hydrochloride from Teva Pharmaceuticals USA, Inc., typically indicating a labeling…

• FDA label_change · 2010-12-01
  FDA Approved: ABILIFY — Supplemental Application (Otsuka America Pharmaceutical, Inc.)

  The FDA approved a supplemental application for ABILIFY (aripiprazole) submitted by Otsuka America Pharmaceutical, Inc., resulting in change…

• FDA label_change · 2010-09-20
  FDA Approved: FLUOXETINE — Supplemental Application (PAI Holdings, LLC dba PAI Pharma)

  FDA approved a supplemental application for fluoxetine hydrochloride by PAI Holdings to modify the product labeling.

• FDA label_change · 2009-12-02
  FDA Approved: SEROQUEL — Supplemental Application (H2-Pharma, LLC)

  The FDA approved a supplemental application for SEROQUEL (quetiapine) submitted by H2-Pharma, LLC, likely involving changes to the drug's la…

• FDA label_change · 2009-07-08
  FDA Approved: TRAZODONE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for trazodone hydrochloride (Teva) resulting in changes to the product labeling.

• FDA label_change · 2009-03-30
  FDA Approved: FLUOXETINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Fluoxetine from Teva Pharmaceuticals USA, Inc., updating the labeling of the approved product.

• FDA label_change · 2008-08-11
  FDA Approved: SEROQUEL XR — Supplemental Application (AstraZeneca Pharmaceuticals LP)

  FDA approved a supplemental application for SEROQUEL XR (quetiapine) submitted by AstraZeneca Pharmaceuticals LP. This approval results in l…

• FDA label_change · 2008-02-13
  FDA Approved: EMSAM — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for EMSAM (selegiline transdermal patch) from Viatris Specialty LLC. This action updates the pro…

• FDA label_change · 2008-02-07
  FDA Approved: EFFEXOR XR — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Effexor XR (venlafaxine hydrochloride) submitted by Viatris Specialty LLC.

• FDA label_change · 2008-01-30
  FDA Approved: EFFEXOR XR — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for Effexor XR (venlafaxine hydrochloride) from Viatris Specialty LLC, updating the product labe…

• FDA label_change · 2007-08-02
  FDA Approved: WELLBUTRIN XL — Supplemental Application (Bausch Health US LLC)

  FDA approved a supplemental application for WELLBUTRIN XL, resulting in changes to the product labeling.

• FDA label_change · 2007-07-12
  FDA Approved: CITALOPRAM — Supplemental Application (Chartwell Governmental & Specialty RX, LLC.)

  FDA approved a supplemental application for citalopram from Chartwell Governmental & Specialty RX, LLC, likely resulting in a labeling updat…

• FDA label_change · 2007-07-03
  FDA Approved: NORTRIPTYLINE HYDROCHLORIDE — Supplemental Application (Dr. Reddy's Laboratories Inc.)

  FDA approved a supplemental application for Nortriptyline hydrochloride from Dr. Reddy's Laboratories, resulting in labeling changes for the…