Dental Pain

• FDA approval · 2024-11-21
  FDA Approved: DICLOFENAC SODIUM — Supplemental Application (NorthStar Rx LLC)

  FDA approved a supplemental application for a generic diclofenac sodium product from NorthStar Rx LLC.

• FDA approval · 2022-01-11
  FDA Approved: CELECOXIB — Supplemental Application (NIVAGEN PHARMACEUTICALS, INC.)

  The FDA approved a supplemental application for Celecoxib submitted by NIVAGEN Pharmaceuticals, Inc., for a generic Celecoxib product.

• FDA approval · 2022-01-05
  FDA Approved: CELECOXIB — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' supplemental application for a generic celecoxib product (Celecoxib) under ANDA 202240.

• FDA approval · 2019-12-03
  FDA Approved: DICLOFENAC POTASSIUM — Original Application (Lifsa Drugs LLC)

  FDA approved the original application for diclofenac potassium as a generic NSAID for relief of pain and inflammation associated with variou…

• FDA approval · 2016-09-02
  FDA Approved: DICLOFENAC SODIUM — Original Application (SOLA Pharmaceuticals, LLC)

  FDA approved SOLA Pharmaceuticals' diclofenac sodium tablet as an original generic, indicated for relief of pain and inflammation in conditi…

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• FDA approval · 2016-05-09
  FDA Approved: DICLOFENAC SODIUM — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for diclofenac sodium from Aurobindo Pharma Limited.

• FDA approval · 2015-04-16
  FDA Approved: CHILDRENS MOTRIN — Supplemental Application (Kenvue Brands LLC)

  FDA approved a supplemental application for Children's Motrin (ibuprofen) from Kenvue Brands LLC, likely to update labeling or expand approv…

• FDA approval · 2012-03-15
  FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)

  FDA approved a supplemental application to add Aleve GelCaps containing naproxen sodium, expanding the approval to include a new dosage form…

• FDA approval · 2010-07-06
  FDA Approved: DICLOFENAC SODIUM — Supplemental Application (Edenbridge Pharmaceuticals LLC.)

  FDA approved a supplemental application for diclofenac sodium from Edenbridge Pharmaceuticals LLC under the ANDA program. This action consti…

• FDA approval · 2007-03-28
  FDA Approved: NAPROXEN — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's naproxen generic under an original ANDA, enabling market access for generic naproxen products.