Anxiety Disorders

• FDA approval · 2014-04-14
  FDA Approved: DIAZEPAM — Original Application (Chartwell RX, LLC)

  FDA approved Chartwell RX, LLC's original application for diazepam oral solution (concentrate) as a generic product.

• FDA approval · 2013-07-22
  FDA Approved: HYDROXYZINE PAMOATE — Supplemental Application (Sandoz Inc)

  The FDA approved a supplemental application for hydroxyzine pamoate submitted by Sandoz Inc. The action relates to a generic product under A…

• FDA approval · 2013-06-27
  FDA Approved: HYDROXYZINE PAMOATE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application from Sandoz Inc for hydroxyzine pamoate (ANDA 087479), authorizing the generic product under the app…

• FDA approval · 2013-06-03
  FDA Approved: HYDROXYZINE PAMOATE — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approved hydroxyzine pamoate as a generic drug under an Original Application by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuti…

• FDA approval · 2013-01-28
  FDA Approved: DIAZEPAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for diazepam from Teva Pharmaceuticals USA, Inc. The action represents an additional approval or mod…

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• FDA approval · 2013-01-28
  FDA Approved: DIAZEPAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for diazepam from Teva Pharmaceuticals USA, Inc., indicating an updated approval-related action for …

• FDA approval · 2012-09-13
  FDA Approved: LORAZEPAM — Supplemental Application (International Medication Systems, Limited)

  FDA approved a supplemental application for lorazepam from International Medication Systems, Limited.

• FDA approval · 2011-06-01
  FDA Approved: ALPRAZOLAM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Alprazolam from Mylan Pharmaceuticals, authorizing a generic alprazolam product. The approva…

• FDA approval · 2010-01-20
  FDA Approved: CLORAZEPATE DIPOTASSIUM — Supplemental Application (NORTHSTAR RX LLC)

  The FDA approved a supplemental application for clorazepate dipotassium submitted by Northstar RX LLC.

• FDA approval · 2010-01-14
  FDA Approved: CLORAZEPATE DIPOTASSIUM — Supplemental Application (Aurolife Pharma LLC)

  FDA approved a supplemental application for Clorazepate Dipotassium by Aurolife Pharma LLC, granting regulatory approval for this generic pr…

• FDA approval · 2009-12-23
  FDA Approved: LORAZEPAM — Original Application (Amneal Pharmaceuticals LLC)

  FDA approves Amneal Pharmaceuticals' generic lorazepam (oral) under an Original Application (ANDA 091383).

• FDA approval · 2009-04-28
  FDA Approved: LORAZEPAM — Original Application (Chartwell RX, LLC)

  FDA approved a generic lorazepam product under Original Application by Chartwell RX, LLC.

• FDA approval · 2009-01-09
  FDA Approved: ALPRAZOLAM — Original Application (Par Health USA, LLC)

  The FDA approved ALPRAZOLAM from Par Health USA, LLC under ANDA078088. It represents a generic version of alprazolam for the treatment of an…

• FDA approval · 2008-09-24
  FDA Approved: HYDROXYZINE HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals LLC)

  The FDA approved Amneal Pharmaceuticals LLC's hydroxyzine hydrochloride as a generic drug under ANDA 040808.

• FDA approval · 2008-09-10
  FDA Approved: LORAZEPAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for lorazepam submitted by Teva Pharmaceuticals USA, Inc., under the existing approval of the dr…

• FDA approval · 2008-08-05
  FDA Approved: HYDROXYZINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for hydroxyzine hydrochloride from Teva Pharmaceuticals USA, Inc., confirming continued approval of …

• FDA approval · 2008-07-23
  FDA Approved: DIAZEPAM — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for diazepam filed by Teva Pharmaceuticals USA, Inc., updating/expanding its labeling.

• FDA approval · 2008-05-29
  FDA Approved: HYDROXYZINE HYDROCHLORIDE — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved Camber Pharmaceuticals' hydroxyzine hydrochloride under an original ANDA; generic entry approved for its existing indications.

• FDA approval · 2008-03-31
  FDA Approved: HYDROXYZINE HYDROCHLORIDE — Original Application (Northstar RxLLC)

  FDA approved Northstar RxLLC's Original Application for hydroxyzine hydrochloride, a generic antihistamine product.

• FDA approval · 2008-02-27
  FDA Approved: MEPROBAMATE — Original Application (Cipla USA Inc.)

  FDA approved the original application for Meprobamate as a generic product from Cipla USA Inc.

• FDA approval · 2007-10-29
  FDA Approved: LORAZEPAM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Lorazepam from Hikma Pharmaceuticals USA Inc., authorizing the marketing of a Lorazepam product.

• FDA approval · 2007-10-09
  FDA Approved: HYDROXYZINE PAMOATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for hydroxyzine pamoate (Teva Pharmaceuticals USA, Inc.). The approval indicates a labeling change a…

• FDA approval · 2007-07-30
  FDA Approved: LORAZEPAM — Original Application (Leading Pharma, LLC)

  FDA approved Lorazepam as a generic drug under an Original Application (ANDA) by Leading Pharma, LLC.

• FDA approval · 2006-11-29
  FDA Approved: LORAZEPAM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for Lorazepam by Hikma Pharmaceuticals USA Inc., authorizing modifications under the supplement.