Trigeminal Neuralgia

• FDA approval · 2026-03-20
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved Torrent Pharmaceuticals Limited's supplemental application for carbamazepine, reflecting an update to the product's labeling un…

• FDA approval · 2026-03-20
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  FDA approved a supplemental application for carbamazepine from Alembic Pharmaceuticals, enabling changes to the product's labeling.

• FDA approval · 2026-03-06
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for carbamazepine from Apotex Corp., granting approval for the generic product under ANDA075948. The…

• FDA approval · 2025-09-30
  FDA Approved: TEGRETOL XR — Supplemental Application (Novartis Pharmaceuticals Corporation)

  FDA approved a supplemental application for Tegretol XR (carbamazepine) submitted by Novartis Pharmaceuticals Corporation.

• FDA approval · 2025-08-15
  FDA Approved: CARBAMAZEPINE ER — Supplemental Application (Bostal LLC)

  FDA approved a supplemental application for Carbamazepine ER submitted by Bostal LLC.

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• FDA approval · 2025-07-01
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Bionpharma Inc.,)

  FDA approved a supplemental application for carbamazepine from Bionpharma Inc. This action confirms regulatory clearance for the product und…

• FDA approval · 2025-01-27
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Torrent Pharmaceuticals Limited)

  FDA approved a supplemental application for Carbamazepine from Torrent Pharmaceuticals Limited under an ANDA.

• FDA approval · 2025-01-14
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Ingenus Pharmaceuticals, LLC)

  FDA approved a supplemental application for a generic Carbamazepine product from Ingenus Pharmaceuticals, LLC.

• FDA approval · 2025-01-14
  FDA Approved: CARBAMAZEPINE — Original Application (Ascend Laboratories, LLC)

  FDA approved a generic carbamazepine product from Ascend Laboratories, LLC under an Original Application (ANDA).

• FDA approval · 2025-01-13
  FDA Approved: CARBAMAZEPINE — Original Application (Torrent Pharmaceuticals Limited)

  FDA approved Torrent Pharmaceuticals Limited's original application for a generic carbamazepine product.

• FDA approval · 2024-08-13
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Northstar Rx LLC)

  FDA approved a supplemental application for carbamazepine from Northstar Rx LLC under ANDA 216594, indicating regulatory approval of changes…

• FDA approval · 2024-01-29
  FDA Approved: CARBAMAZEPINE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for carbamazepine submitted by ANI Pharmaceuticals, Inc.

• FDA approval · 2024-01-29
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Chartwell RX, LLC)

  FDA approved a supplemental application to permit Chartwell RX, LLC to market a generic carbamazepine product under an ANDA.

• FDA approval · 2024-01-29
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approved a supplemental application for carbamazepine from Zydus Pharmaceuticals (USA) Inc., updating the approved generic product.

• FDA approval · 2024-01-29
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for carbamazepine by Rising Pharma Holdings, Inc.

• FDA approval · 2024-01-09
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved a supplemental application for carbamazepine by Upsher-Smith Laboratories, with changes to its approved labeling and indication…

• FDA approval · 2023-12-22
  FDA Approved: CARBAMAZEPINE — Supplemental Application (NIVAGEN PHARMACEUTICALS, INC.)

  FDA approved a supplemental application for Carbamazepine from NIVAGEN Pharmaceuticals, authorizing changes to the generic product under the…

• FDA approval · 2023-12-11
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Unichem Pharmaceuticals (USA), Inc.)

  The FDA approved a supplemental application for carbamazepine filed by Unichem Pharmaceuticals (USA), Inc., signaling an approved change to …

• FDA approval · 2023-09-13
  FDA Approved: TEGRETOL — Supplemental Application (Novartis Pharmaceuticals Corporation)

  The FDA approved a supplemental application for Tegretol (carbamazepine) filed by Novartis Pharmaceuticals Corporation.

• FDA approval · 2023-03-24
  FDA Approved: CARBAMAZEPINE — Original Application (Ajanta Pharma USA Inc.)

  FDA approved Ajanta Pharma USA's original ANDA for carbamazepine (generic anticonvulsant). This marks the availability of a generic carbamaz…

• FDA approval · 2023-03-02
  FDA Approved: CARBAMAZEPINE ER — Original Application (Epic Pharma, LLC)

  FDA approves the first original-application generic Carbamazepine ER from Epic Pharma, LLC under ANDA 216235. This extended-release formulat…

• FDA approval · 2022-12-02
  FDA Approved: CARBAMAZEPINE — Original Application (Ingenus Pharmaceuticals, LLC)

  FDA approved the original application for a generic carbamazepine product from Ingenus Pharmaceuticals, LLC.

• FDA approval · 2022-11-21
  FDA Approved: EPITOL — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for EPITOL (carbamazepine) from Teva Pharmaceuticals USA, Inc. This action approves changes to the p…

• FDA approval · 2022-11-09
  FDA Approved: CARBAMAZEPINE — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for carbamazepine filed by ANI Pharmaceuticals, Inc.

• FDA approval · 2022-11-08
  FDA Approved: CARBAMAZEPINE — Supplemental Application (Apotex Corp.)

  The FDA approved a supplemental application for Carbamazepine submitted by Apotex Corp., a generic formulation.