Essential Tremor

• EMA approval · 2024-11-15
  EMA Authorised: Celsunax (ioflupane (123i)) — Pinax Pharma GmbH

  EMA authorised Celsunax (ioflupane (123I)) by Pinax Pharma GmbH for radionuclide imaging to aid the assessment of movement disorders and dem…

• FDA approval · 2024-07-11
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Lannett Company, Inc.)

  FDA approved a supplemental application for propranolol hydrochloride by Lannett Company, Inc., approving changes to the existing ANDA to su…

• FDA approval · 2023-11-07
  FDA Approved: INDERAL LA — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Inderal LA (propranolol hydrochloride) by ANI Pharmaceuticals, Inc. The action confirms regulato…

• FDA approval · 2023-09-12
  FDA Approved: IOFLUPANE I 123 — Supplemental Application (Curium US LLC)

  FDA approved a supplemental application for IOFLUPANE I-123 (DaTSCAN) from Curium US LLC.

• FDA approval · 2022-11-30
  FDA Approved: DATSCAN — Supplemental Application (Medi-Physics Inc. dba GE Healthcare.)

  FDA approved a supplemental application for DATSCAN (IOFLUPANE I-123) by Medi-Physics Inc. dba GE Healthcare, indicating an update to the la…

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• FDA approval · 2022-11-01
  FDA Approved: DATSCAN — Supplemental Application (Medi-Physics Inc. dba GE Healthcare.)

  FDA approved a supplemental application for DATSCAN (ioflupane I-123) by Medi-Physics Inc. dba GE Healthcare.

• FDA approval · 2022-03-30
  FDA Approved: IOFLUPANE I 123 — Original Application (Curium US LLC)

  The FDA approved IOFLUPANE I-123 (IOFLUPANE I-123) from Curium US LLC in an Original Application as a dopamine transporter imaging agent for…

• FDA approval · 2020-01-06
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Original Application (Lannett Company, Inc.)

  FDA approved the original application for propranolol hydrochloride from Lannett Company, Inc., enabling a generic version to be marketed.

• FDA approval · 2019-03-22
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Breckenridge Pharmaceutical, Inc.)

  The FDA approved Breckenridge Pharmaceutical's supplemental application for propranolol hydrochloride (generic propranolol HCl).

• FDA approval · 2015-12-21
  FDA Approved: INDERAL LA — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approves a supplemental application for Inderal LA (propranolol hydrochloride) by ANI Pharmaceuticals, Inc., granting approval for chang…

• FDA approval · 2015-01-22
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for Propranolol Hydrochloride from Amneal Pharmaceuticals NY LLC, indicating approval for this gener…

• FDA approval · 2014-12-09
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental ANDA for propranolol hydrochloride by Amneal Pharmaceuticals NY LLC, authorizing a new generic propranolol hydro…

• FDA approval · 2013-11-19
  FDA Approved: INNOPRAN XL — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved ANI Pharmaceuticals' supplemental application for INNOPRAN XL (propranolol hydrochloride). The approval confirms changes to the…

• FDA approval · 2012-01-27
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Ipca Laboratories Limited)

  FDA approved a supplemental application for propranolol hydrochloride from Ipca Laboratories Limited, finalizing a regulatory update for the…

• FDA approval · 2012-01-27
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Endo USA, Inc.)

  FDA approved Endo USA, Inc.'s supplemental application for propranolol hydrochloride, indicating the generic product's supplemental filing h…

• FDA approval · 2011-03-17
  FDA Approved: INDERAL LA — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Inderal LA (propranolol hydrochloride) filed by ANI Pharmaceuticals, Inc.

• FDA approval · 2011-01-14
  FDA Approved: DATSCAN — Original Application (Medi-Physics Inc. dba GE Healthcare.)

  FDA approved the original application for DATSCAN (ioflupane I-123), a radiopharmaceutical for brain imaging to aid in differentiating Parki…

• FDA approval · 2008-09-10
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for propranolol hydrochloride from Hikma Pharmaceuticals USA Inc., indicating regulatory approval of…

• FDA approval · 2008-03-20
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approves a supplemental application for propranolol hydrochloride from Amneal Pharmaceuticals NY LLC.

• FDA approval · 2008-03-20
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved a supplemental application for propranolol hydrochloride from Amneal Pharmaceuticals NY LLC, signifying approval of a gener…

• FDA approval · 2008-01-31
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a generic version of propranolol hydrochloride for the same indications as the brand product, enabling generic competition for …

• FDA approval · 2008-01-07
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for propranolol hydrochloride from Amneal Pharmaceuticals NY LLC.

• FDA approval · 2007-08-10
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Original Application (Actavis Pharma, Inc.)

  The FDA approved Actavis Pharma's generic propranolol hydrochloride product in an Original ANDA submission.

• FDA approval · 2007-06-21
  FDA Approved: PROPRANOLOL HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for propranolol hydrochloride (generic) from Hikma Pharmaceuticals USA Inc., indicating an approval …

• FDA approval · 2007-01-03
  FDA Approved: INDERAL LA — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for INDERAL LA (propranolol hydrochloride) submitted by ANI Pharmaceuticals, Inc. This action au…