Status Epilepticus

• FDA approval · 2025-11-14
  FDA Approved: DIAZEPAM — Original Application (Navinta LLC)

  FDA approved Navinta LLC's generic diazepam through an Original Application (ANDA 217468).

• FDA approval · 2024-06-07
  FDA Approved: LORAZEPAM — Supplemental Application (International Medication Systems, Limited)

  FDA approved a supplemental application for lorazepam from International Medication Systems, Limited (ANDA 076150).

• FDA approval · 2023-10-13
  FDA Approved: FOSPHENYTOIN SODIUM — Original Application (Sagent Pharmaceuticals)

  FDA approved an original generic application for fosphenytoin sodium, enabling a generic version of this anticonvulsant to be marketed by Sa…

• FDA approval · 2023-09-27
  FDA Approved: LORAZEPAM — Supplemental Application (Aurolife Pharma LLC)

  The FDA approved a supplemental application for lorazepam from Aurolife Pharma LLC, enabling the commercialization of a generic Lorazepam pr…

• FDA approval · 2023-07-10
  FDA Approved: DIAZEPAM — Supplemental Application (Oceanside Pharmaceuticals)

  FDA approved a supplemental application for Diazepam from Oceanside Pharmaceuticals.

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• FDA approval · 2023-04-25
  FDA Approved: DIAZEPAM — Supplemental Application (Hospira, Inc.)

  FDA approved Hospira's supplemental application for diazepam (generic) under ANDA 071583. This represents a supplemental approval for a gene…

• FDA approval · 2023-02-08
  FDA Approved: DIAZEPAM — Supplemental Application (Natco Pharma USA LLC)

  FDA approves a supplemental application for Diazepam by Natco Pharma USA LLC, approving a supplemental change to the generic diazepam produc…

• FDA approval · 2023-01-17
  FDA Approved: DIAZEPAM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for diazepam submitted by Hikma Pharmaceuticals USA Inc., marking regulatory action to support t…

• FDA approval · 2023-01-17
  FDA Approved: DIAZEPAM — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application for diazepam oral solution concentrate from Chartwell RX, LLC, adding/confirming approval for this d…

• FDA approval · 2023-01-17
  FDA Approved: MIDAZOLAM — Supplemental Application (Steriscience Specialties Private Limited)

  FDA approved a supplemental application for Midazolam hydrochloride (Midazolam) by Steriscience Specialties Private Limited under an ANDA.

• FDA approval · 2023-01-13
  FDA Approved: ATIVAN — Supplemental Application (Bausch Health US LLC)

  The FDA approved a supplemental application for ATIVAN (lorazepam) submitted by Bausch Health US LLC. The action indicates a label update or…

• FDA approval · 2023-01-13
  FDA Approved: LOREEV XR — Supplemental Application (Almatica Pharma LLC)

  The FDA approved a supplemental application for LOREEV XR (lorazepam) submitted by Almatica Pharma LLC.

• FDA approval · 2023-01-13
  FDA Approved: VALIUM — Supplemental Application (Roche Laboratories Inc.)

  The FDA approved a supplemental application for Valium (diazepam) from Roche Laboratories Inc., updating the existing NDA.

• FDA approval · 2023-01-11
  FDA Approved: DIAZEPAM — Supplemental Application (Natco Pharma USA LLC)

  FDA approved a supplemental application for diazepam (generic) from Natco Pharma USA LLC under ANDA210363.

• FDA approval · 2022-11-17
  FDA Approved: SEZABY — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved SEZABY (phenobarbital sodium) from Sun Pharmaceutical Industries via an original NDA. It is an anticonvulsant indicated for sei…

• FDA approval · 2022-11-10
  FDA Approved: DIAZEPAM — Original Application (Fresenius Kabi USA, LLC)

  The FDA approved Fresenius Kabi USA, LLC's Original Application for diazepam (generic diazepam). This approval adds a new generic option for…

• FDA approval · 2021-06-23
  FDA Approved: DIAZEPAM — Supplemental Application (Natco Pharma USA LLC)

  FDA approved Natco Pharma USA LLC's supplemental application for Diazepam (generic).

• FDA approval · 2021-03-25
  FDA Approved: DIAZEPAM — Supplemental Application (Oceanside Pharmaceuticals)

  FDA supplemental approval for Diazepam under Oceanside Pharmaceuticals is recorded, confirming the approval of a supplemental application fo…

• FDA approval · 2021-02-08
  FDA Approved: DIAZEPAM — Supplemental Application (Natco Pharma USA LLC)

  FDA approved a supplemental application for Diazepam (generic) from Natco Pharma USA LLC under an ANDA. The action confirms approval of the …

• FDA approval · 2021-02-05
  FDA Approved: DIAZEPAM — Supplemental Application (Hospira, Inc.)

  FDA approved a supplemental application for diazepam from Hospira, Inc., under an ANDA, indicating regulatory approval of the requested chan…

• FDA approval · 2021-02-05
  FDA Approved: DIAZEPAM — Supplemental Application (Meridian Medical Technologies LLC)

  The FDA approved a supplemental application for Diazepam submitted by Meridian Medical Technologies LLC.

• FDA approval · 2021-02-05
  FDA Approved: DIAZEPAM — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for Diazepam, approving a generic version of the drug.

• FDA approval · 2020-10-02
  FDA Approved: LORAZEPAM — Supplemental Application (Amneal Pharmaceuticals LLC)

  FDA approved a supplemental application for Lorazepam from Amneal Pharmaceuticals LLC. The approval updates labeling/indication for the Lora…

• FDA approval · 2020-08-28
  FDA Approved: FOSPHENYTOIN — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for fosphenytoin sodium (Fosphenytoin) from Fresenius Kabi USA, LLC. The action confirms an approved…

• FDA approval · 2020-08-07
  FDA Approved: DILANTIN — Supplemental Application (Viatris Specialty LLC)

  The FDA approved a supplemental application for DILANTIN Extended Phenytoin Sodium filed by Viatris Specialty LLC.