Insomnia

• FDA approval · 2017-12-22
  FDA Approved: LORAZEPAM — Original Application (Aurolife Pharma LLC)

  FDA approved Aurolife's original application for lorazepam, a generic benzodiazepine.

• FDA approval · 2017-09-11
  FDA Approved: ZOLPIDEM TARTRATE SUBLINGUAL — Original Application (ENDO USA, Inc.)

  FDA approved a generic zolpidem tartrate sublingual tablet under ANDA 204229 from ENDO USA, Inc. for the treatment of insomnia.

• FDA approval · 2017-03-30
  FDA Approved: ADVIL PM- DIPHENHYDRAMINE CITRATE AND IBUPROFEN TABLET, COATED — Supplemental Application (Lil Drug Store Products, Inc)

  FDA approved a supplemental application for Advil PM, a combination ibuprofen and diphenhydramine citrate tablet, submitted by Lil Drug Stor…

• FDA approval · 2017-03-03
  FDA Approved: AMBIEN — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for AMBIEN (zolpidem tartrate) from Cosette Pharmaceuticals, Inc.

• FDA approval · 2017-01-24
  FDA Approved: ZOLPIDEM TARTRATE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical Industries, Inc.'s zolpidem tartrate as an Original Application (ANDA), providing a generic option for the t…

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• FDA approval · 2016-12-28
  FDA Approved: IBUPROFEN PM — Supplemental Application (TOP CARE (Topco Associates LLC))

  FDA approved a supplemental application for Ibuprofen PM (ibuprofen with diphenhydramine HCl) from Top Care (Topco Associates LLC), signalin…

• FDA approval · 2016-12-16
  FDA Approved: HALCION — Supplemental Application (Pharmacia & Upjohn Company LLC)

  FDA approved a supplemental application for HALCION (triazolam) from Pharmacia & Upjohn Company LLC. The submission status indicates the sup…

• FDA approval · 2016-12-16
  FDA Approved: ESTAZOLAM — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for Estazolam from Actavis Pharma, Inc., authorizing a labeling modification under the supplemental …

• FDA approval · 2016-12-16
  FDA Approved: RESTORIL — Supplemental Application (SpecGx LLC)

  FDA approved a supplemental application for RESTORIL (temazepam) submitted by SpecGx LLC.

• FDA approval · 2016-12-16
  FDA Approved: FLURAZEPAM HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for Flurazepam hydrochloride (generic) to Chartwell RX, LLC, authorizing continued marketing of this…

• FDA approval · 2016-12-16
  FDA Approved: ESTAZOLAM — Supplemental Application (Dr. Reddy's Labratories Inc.)

  FDA approved a supplemental application for ESTAZOLAM by Dr. Reddy's Laboratories Inc.

• FDA approval · 2016-12-16
  FDA Approved: ESTAZOLAM — Supplemental Application (Novitium Pharma LLC)

  FDA approved a supplemental application for estazolam filed by Novitium Pharma LLC.

• FDA approval · 2016-12-16
  FDA Approved: FLURAZEPAM HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for flurazepam hydrochloride from Chartwell RX, LLC, updating the approval of the generic product.

• FDA approval · 2016-12-02
  FDA Approved: AMBIEN — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for AMBIEN (zolpidem tartrate) submitted by Cosette Pharmaceuticals, Inc.

• FDA approval · 2016-11-08
  FDA Approved: HYDROXYZINE HYDROCHLORIDE — Supplemental Application (Chartwell RX, LLC)

  The FDA approved a supplemental application for hydroxyzine hydrochloride from Chartwell RX, LLC, authorizing a generic version under ANDA04…

• FDA approval · 2016-11-08
  FDA Approved: HYDROXYZINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva's supplemental application for hydroxyzine hydrochloride, confirming approval of an additional submission for this generic…

• FDA approval · 2016-11-02
  FDA Approved: UP AND UP IBUPROFEN PM — Supplemental Application (Target Corporation)

  FDA approved a supplemental application for Target's Up and Up Ibuprofen PM, a diphenhydramine citrate and ibuprofen combination product int…

• FDA approval · 2016-09-15
  FDA Approved: ESZOPICLONE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original ANDA for Eszopiclone by Aurobindo Pharma Limited, providing a generic version of the insomnia medication.

• FDA approval · 2016-08-11
  FDA Approved: AMBIEN — Supplemental Application (Cosette Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for AMBIEN (zolpidem tartrate) submitted by Cosette Pharmaceuticals, Inc. This approval pertains…

• FDA approval · 2016-08-11
  FDA Approved: ZOLPIDEM TARTRATE — Supplemental Application (Sanofi-Aventis U.S. LLC)

  FDA approved a supplemental application for zolpidem tartrate submitted by Sanofi-Aventis U.S. LLC.

• FDA approval · 2016-05-27
  FDA Approved: BELSOMRA — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for BELSOMRA (suvorexant) by Merck Sharp & Dohme LLC.

• FDA approval · 2016-05-23
  FDA Approved: TEMAZEPAM — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals' Temazepam as an Original Application for a generic product. Temazepam is indicated for the short-term t…

• FDA approval · 2016-05-23
  FDA Approved: PENTOBARBITAL SODIUM — Original Application (Sagent Pharmaceuticals)

  The FDA approved an Original Application (ANDA) for pentobarbital sodium from Sagent Pharmaceuticals, establishing a generic version of this…

• FDA approval · 2016-05-03
  FDA Approved: BELSOMRA — Supplemental Application (Merck Sharp & Dohme LLC)

  The FDA approved a supplemental application for BELSOMRA (suvorexant) submitted by Merck Sharp & Dohme LLC.

• FDA approval · 2016-03-30
  FDA Approved: HYDROXYZINE HYDROCHLORIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for hydroxyzine hydrochloride by Teva Pharmaceuticals USA, Inc., under ANDA088617.