Orthostatic Hypotension

• FDA approval · 2025-05-08
  FDA Approved: MIDODRINE HYDROCHLORIDE — Supplemental Application (Lifestar Pharma LLC)

  FDA approved a supplemental application for midodrine hydrochloride (generic) by Lifestar Pharma LLC.

• FDA approval · 2023-11-01
  FDA Approved: MIDODRINE HYDROCHLORIDE — Original Application (Lifestar Pharma LLC)

  FDA approved the original abbreviated new drug application for midodrine hydrochloride, a generic version manufactured by Lifestar Pharma LL…

• FDA approval · 2023-10-17
  FDA Approved: MIDODRINE HYDROCHLORIDE — Original Application (Novugen Pharma (USA) LLC)

  FDA approved the original abbreviated new drug application for midodrine hydrochloride, enabling a generic version of the medication.

• FDA approval · 2022-05-31
  FDA Approved: FLUDROCORTISONE ACETATE — Original Application (Novitium Pharma LLC)

  FDA approved the original generic application for fludrocortisone acetate (ANDA 215279) from Novitium Pharma LLC. This approval makes a gene…

• FDA approval · 2021-02-18
  FDA Approved: DROXIDOPA — Original Application (Aurobindo Pharma Limited)

  FDA approved a generic version of droxidopa under an Original Application (ANDA 214387) from Aurobindo Pharma Limited.

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• FDA approval · 2021-01-21
  FDA Approved: MIDODRINE HYDROCHLORIDE — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approved Alembic Pharmaceuticals' generic Midodrine Hydrochloride for the treatment of orthostatic hypotension (original ANDA approval).

• FDA approval · 2020-10-01
  FDA Approved: MIDODRINE HYDROCHLORIDE — Original Application (Xiromed, LLC)

  FDA approved Midodrine Hydrochloride under an original Abbreviated New Drug Application (ANDA) for Xiromed, LLC.

• FDA approval · 2020-09-01
  FDA Approved: MIDODRINE HYDROCHLORIDE — Original Application (Zydus Lifesciences Limited)

  FDA approved a generic version of midodrine hydrochloride from Zydus Lifesciences Limited under an original application. The product is inte…

• FDA approval · 2020-08-10
  FDA Approved: MIDODRINE HYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)

  FDA approved MIDODRINE HYDROCHLORIDE from Aurobindo Pharma Limited as a generic drug under an Original Application (ANDA 212774).

• FDA approval · 2019-11-20
  FDA Approved: MIDODRINE HYDROCHLORIDE — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for Midodrine hydrochloride from NorthStar Rx LLC, enabling its generic product to be marketed under…

• FDA approval · 2019-11-13
  FDA Approved: MIDODRINE HYDROCHLORIDE — Supplemental Application (Upsher-Smith laboratories, LLC)

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

• FDA approval · 2019-11-13
  FDA Approved: MIDODRINE HYDROCHLORIDE — Supplemental Application (Apotex Corp)

  FDA approved a supplemental application for Apotex Corp's generic midodrine hydrochloride.

• FDA approval · 2019-11-04
  FDA Approved: MIDODRINE HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

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

• FDA approval · 2019-08-19
  FDA Approved: MIDODRINE HYDROCHLORIDE — Original Application (NorthStar Rx LLC)

  FDA approved the original application for Midodrine Hydrochloride (generic Midodrine), used to treat orthostatic hypotension.

• FDA approval · 2018-11-02
  FDA Approved: MIDODRINE HYDROCHLORIDE — Original Application (Umasuto, LLC)

  The FDA approved a generic midodrine hydrochloride product from Umasuto, LLC under an original application (ANDA), authorizing its marketing…

• FDA approval · 2017-02-10
  FDA Approved: NORTHERA — Supplemental Application (Lundbeck Pharmaceuticals LLC)

  The FDA approved a supplemental application for Northera (droxidopa) submitted by Lundbeck Pharmaceuticals LLC. This action approves changes…

• FDA approval · 2006-09-12
  FDA Approved: MIDODRINE HYDROCHLORIDE — Original Application (Apotex Corp)

  The FDA approved Apotex Corp's original application for Midodrine Hydrochloride, a generic version of midodrine.