Shift Work Sleep Disorder

• FDA approval · 2023-06-21
  FDA Approved: MODAFINIL — Supplemental Application (Apotex Corp.)

  FDA approved Apotex Corp.'s supplemental application for a generic modafinil product (ANDA077667), enabling its marketing in the United Stat…

• FDA approval · 2021-05-11
  FDA Approved: MODAFINIL — Supplemental Application (Apotex Corp.)

  The FDA approved a supplemental application from Apotex Corp. for Modafinil, authorizing a generic version of the wakefulness-promoting drug…

• FDA approval · 2021-01-28
  FDA Approved: MODAFINIL — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  FDA approved a supplemental application for modafinil submitted by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

• FDA approval · 2020-12-18
  FDA Approved: MODAFINIL — Supplemental Application (Rising Pharma Holdings, Inc.)

  The FDA approved a supplemental application for modafinil from Rising Pharma Holdings, Inc., resulting in a labeling change for the product.

• FDA approval · 2019-12-13
  FDA Approved: ARMODAFINIL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for ARMODAFINIL submitted by Mylan Pharmaceuticals Inc.

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• FDA approval · 2019-05-09
  FDA Approved: ARMODAFINIL — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved Mylan's original ANDA for armodafinil, a generic wakefulness-promoting drug, for the treatment of excessive daytime sleepiness …

• FDA approval · 2018-03-06
  FDA Approved: ARMODAFINIL — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's armodafinil as a generic product under an Original ANDA. It is indicated for excessive daytime sleep…

• FDA approval · 2017-09-14
  FDA Approved: MODAFINIL — Original Application (Zydus Lifesciences Limited)

  FDA approves the original generic application for modafinil by Zydus Lifesciences Limited.

• FDA approval · 2017-08-16
  FDA Approved: MODAFINIL — Original Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)

  The FDA approves an original generic application for modafinil, manufactured by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc…

• FDA approval · 2017-02-07
  FDA Approved: NUVIGIL — Supplemental Application (Cephalon, LLC)

  FDA approved a supplemental application for NuVigil (armodafinil) submitted by Cephalon, LLC.

• FDA approval · 2016-11-28
  FDA Approved: ARMODAFINIL — Original Application (Natco Pharma USA LLC)

  The FDA approved Natco Pharma USA LLC's original application for armodafinil, enabling generic armodafinil to enter the market.

• FDA approval · 2016-06-15
  FDA Approved: MODAFINIL — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for Modafinil from Alembic Pharmaceuticals Limited. The approval confirms the ability to market the …

• FDA approval · 2016-01-28
  FDA Approved: MODAFINIL — Supplemental Application (Bionpharma Inc.)

  FDA approved a supplemental application for modafinil filed by Bionpharma Inc. to market a generic wakefulness-promoting drug.

• FDA approval · 2016-01-20
  FDA Approved: ARMODAFINIL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for armodafinil filed by Mylan Pharmaceuticals, granting regulatory approval for the indicated s…

• FDA approval · 2015-04-16
  FDA Approved: NUVIGIL — Supplemental Application (Cephalon, LLC)

  The FDA approved a supplemental application for NUVIGIL (armodafinil) filed by Cephalon, LLC.

• FDA approval · 2015-02-09
  FDA Approved: NUVIGIL — Supplemental Application (Cephalon, LLC)

  The FDA approved a supplemental application for Nuvigil (armodafinil) filed by Cephalon, LLC.

• FDA approval · 2015-01-15
  FDA Approved: MODAFINIL — Supplemental Application (CIMA LABS INC.)

  The FDA approved a supplemental application for Modafinil submitted by CIMA Labs Inc., resulting in updated regulatory labeling for the prod…

• FDA approval · 2014-11-05
  FDA Approved: MODAFINIL — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for Modafinil submitted by Rising Pharma Holdings, Inc. The approval indicates the sponsor's supplem…

• FDA approval · 2014-02-03
  FDA Approved: MODAFINIL — Original Application (Apotex Corp.)

  The FDA approved the original application for generic modafinil by Apotex Corp., authorizing their modafinil product as a generic version.

• FDA approval · 2012-10-18
  FDA Approved: MODAFINIL — Original Application (Alembic Pharmaceuticals Limited)

  FDA approves Alembic Pharmaceuticals Limited's Original Application for Modafinil as a generic version of the wakefulness-promoting drug. Th…

• FDA approval · 2012-09-27
  FDA Approved: MODAFINIL — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved a generic form of modafinil from Rising Pharma Holdings, Inc.

• FDA approval · 2012-09-26
  FDA Approved: MODAFINIL — Original Application (Bionpharma Inc.)

  FDA approved Bionpharma's original application for a generic Modafinil product, authorizing marketing in the United States for the treatment…

• FDA approval · 2012-06-01
  FDA Approved: ARMODAFINIL — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved an original application for armodafinil from Mylan Pharmaceuticals Inc., enabling a generic version of the wakefulness-promotin…

• FDA approval · 2010-10-21
  FDA Approved: MODAFINIL — Supplemental Application (CIMA LABS INC.)

  FDA approved a supplemental application for modafinil submitted by CIMA Labs, resulting in changes to the drug's labeling.

• FDA approval · 2009-03-26
  FDA Approved: NUVIGIL — Supplemental Application (Cephalon, LLC)

  FDA approved a supplemental application for NUVIGIL (armodafinil) submitted by Cephalon, LLC. This approval covers changes to the product la…