Alzheimer Disease

• FDA approval · 2019-12-03
  FDA Approved: GALANTAMINE HYDROBROMIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for galantamine hydrobromide (Sun Pharmaceutical Industries, Inc.) under ANDA090178, resulting in an…

• FDA approval · 2019-11-26
  FDA Approved: RIVASTIGMINE TRANSDERMAL SYSTEM — Original Application (Breckenridge Pharmaceutical, Inc.)

  FDA approved Breckenridge Pharmaceutical's rivastigmine transdermal system (patch) through an Original ANDA, expanding generic options for t…

• FDA approval · 2019-10-24
  FDA Approved: GALANTAMINE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for galantamine from Aurobindo Pharma Limited, expanding regulatory authorization under an existing …

• FDA approval · 2019-09-24
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for donepezil hydrochloride from Upsher-Smith Laboratories, LLC.

• FDA approval · 2019-09-20
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Supplemental Application (Edenbridge Pharmaceuticals LLC.)

  The FDA approved a supplemental application for donepezil hydrochloride from Edenbridge Pharmaceuticals LLC., a generic treatment for Alzhei…

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• FDA approval · 2019-07-23
  FDA Approved: RIVASTIGMINE TARTRATE — Supplemental Application (Nivagen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for rivastigmine tartrate from Nivagen Pharmaceuticals, Inc., enabling a generic rivastigmine tartra…

• FDA approval · 2019-07-22
  FDA Approved: RIVASTIGMINE TARTRATE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for rivastigmine tartrate by Alembic Pharmaceuticals Limited, authorizing a generic rivastigmine tar…

• FDA approval · 2019-07-16
  FDA Approved: RIVASTIGMINE TARTRATE — Supplemental Application (Dr. Reddy's Laboratories Limited)

  FDA approved a supplemental application for a generic rivastigmine tartrate product from Dr. Reddy's Laboratories (ANDA). Rivastigmine tartr…

• FDA approval · 2019-06-28
  FDA Approved: MEMANTINE HYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

  FDA approved a supplemental application for memantine hydrochloride from Macleods Pharmaceuticals Limited under the ANDA program, approving …

• FDA approval · 2019-06-28
  FDA Approved: MEMANTINE — Supplemental Application (NorthStar RxLLC)

  The FDA approved a supplemental application for memantine submitted by NorthStar RxLLC.

• FDA approval · 2019-06-28
  FDA Approved: MEMANTINE HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for memantine hydrochloride, a generic form of memantine used to treat Alzheime…

• FDA approval · 2019-06-28
  FDA Approved: MEMANTINE HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for memantine hydrochloride from Aurobindo Pharma Limited. The action updates the approved product u…

• FDA approval · 2019-06-28
  FDA Approved: MEMANTINE HYDROCHLORIDE — Supplemental Application (Viona Pharmaceuticals Inc)

  FDA approves a supplemental application for Memantine Hydrochloride from Viona Pharmaceuticals Inc.

• FDA approval · 2019-06-28
  FDA Approved: MEMANTINE — Supplemental Application (Chartwell RX, LLC)

  The FDA approved Chartwell RX LLC's supplemental application for memantine. This action approves a supplemental filing for a generic memanti…

• FDA approval · 2019-06-28
  FDA Approved: MEMANTINE HYDROCHLORIDE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for memantine hydrochloride from Upsher-Smith Laboratories, LLC.

• FDA approval · 2019-06-28
  FDA Approved: MEMANTINE HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for memantine hydrochloride by Amneal Pharmaceuticals of New York LLC. The approval concerns a g…

• FDA approval · 2019-05-31
  FDA Approved: MEMANTINE HYDROCHLORIDE — Supplemental Application (Alembic Pharmaceuticals Limited)

  FDA approved a supplemental application for memantine hydrochloride from Alembic Pharmaceuticals Limited, authorizing a generic version for …

• FDA approval · 2019-05-21
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for a generic donepezil hydrochloride product from Rising Pharma Holdings, Inc.

• FDA approval · 2019-05-21
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  The FDA approved a supplemental ANDA for donepezil hydrochloride, permitting a generic version of the Alzheimer's disease therapy.

• FDA approval · 2019-05-21
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Supplemental Application (Dr. Reddys Laboratories Limited)

  FDA approved a supplemental application for donepezil hydrochloride from Dr. Reddys Laboratories Limited. This action signifies regulatory a…

• FDA approval · 2019-05-20
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for donepezil hydrochloride by Torrent Pharmaceuticals Limited.

• FDA approval · 2019-05-20
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Supplemental Application (Cadila Pharmaceuticals Limited)

  FDA approved Cadila Pharmaceuticals Limited's supplemental application for donepezil hydrochloride, a drug used to treat Alzheimer's disease…

• FDA approval · 2019-05-20
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  FDA approved a supplemental application for donepezil hydrochloride, a generic Alzheimer's disease medication, submitted by Unichem Pharmace…

• FDA approval · 2019-04-23
  FDA Approved: DONEPEZIL HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for donepezil hydrochloride, enabling a generic version of the Alzheimer's dise…

• FDA approval · 2019-04-16
  FDA Approved: RIVASTIGMINE TARTRATE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for rivastigmine tartrate filed by Sun Pharmaceutical Industries, Inc.