Pain

• FDA approval · 2019-09-23
  FDA Approved: BUPRENORPHINE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for buprenorphine from Actavis Pharma, Inc., associated with an existing approved product.

• FDA approval · 2019-09-10
  FDA Approved: ACETAMINOPHEN AND CODEINE PHOSPHATE — Original Application (Elite Laboratories, Inc.)

  The FDA approved a generic acetaminophen and codeine phosphate combination from Elite Laboratories under an original application.

• FDA approval · 2019-09-09
  FDA Approved: HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Supplemental Application (Epic Pharma, LLC)

  FDA approved a supplemental ANDA for Hydrocodone Bitartrate and Acetaminophen by Epic Pharma, LLC.

• FDA approval · 2019-08-22
  FDA Approved: METHADONE HYDROCHLORIDE — Original Application (SpecGx LLC)

  FDA approved a generic methadone hydrochloride product (SpecGx LLC) under an Original Application.

• FDA approval · 2019-08-07
  FDA Approved: CELECOXIB — Original Application (AiPing Pharmaceutical, Inc.)

  The FDA approved AiPing Pharmaceutical, Inc.'s original ANDA for celecoxib, establishing a generic version of the COX-2 inhibitor. The appro…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2019-07-25
  FDA Approved: CELECOXIB — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves Aurobindo Pharma Limited's supplemental application for Celecoxib (generic Celecoxib), confirming the generic's approval. Celec…

• FDA approval · 2019-07-22
  FDA Approved: IBUPROFEN — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for ibuprofen by Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2019-04-05
  FDA Approved: KETOROLAC TROMETHAMINE — Original Application (Micro Labs Limited)

  FDA approved the Original Application for ketorolac tromethamine from Micro Labs Limited, allowing the generic version to be marketed.

• FDA approval · 2019-01-24
  FDA Approved: OXYCODONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)

  FDA approved a supplemental application for a generic oxycodone hydrochloride product from SpecGx LLC.

• FDA approval · 2019-01-03
  FDA Approved: METHADONE HYDROCHLORIDE — Original Application (Camber Pharmaceuticals, Inc)

  FDA approved Camber Pharmaceuticals' Methadone Hydrochloride Original Application (ANDA 211228).

• FDA approval · 2018-11-23
  FDA Approved: CHILDRENS IBUPROFEN ORAL SUSPENSION, DYE FREE — Original Application (Best Choice)

  FDA approved a dye-free children's ibuprofen oral suspension from Best Choice under an original ANDA, enabling a generic version for fever a…

• FDA approval · 2018-11-20
  FDA Approved: BUPRENORPHINE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved Teva Pharmaceuticals USA, Inc.'s original application for generic buprenorphine, enabling its marketing in the United States fo…

• FDA approval · 2018-11-15
  FDA Approved: KETOROLAC TROMETHAMINE — Original Application (Aurobindo Pharma Limited)

  FDA approved the original application for Ketorolac tromethamine from Aurobindo Pharma Limited, granting a generic approval for short-term m…

• FDA approval · 2018-10-31
  FDA Approved: BUPRENORPHINE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for buprenorphine from Hikma Pharmaceuticals USA Inc., granting approval for changes to an already-a…

• FDA approval · 2018-10-31
  FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)

  FDA approved a supplemental application for buprenorphine hydrochloride (ANDA090622) filed by PAI Holdings, LLC dba Pharmaceutical Associate…

• FDA approval · 2018-10-31
  FDA Approved: BUPRENORPHINE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for buprenorphine submitted by Actavis Pharma, Inc. under ANDA090819. The action confirms approval o…

• FDA approval · 2018-10-29
  FDA Approved: HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Original Application (Eywa Pharma Inc)

  FDA approved Eywa Pharma's generic hydrocodone bitartrate and acetaminophen for short-term relief of moderate to moderately severe acute pai…

• FDA approval · 2018-10-26
  FDA Approved: XTAMPZA ER — Supplemental Application (Collegium Pharmaceutical, Inc.)

  The FDA approved a supplemental application for Xtampza ER (oxycodone) from Collegium Pharmaceutical, Inc., marking an update to the product…

• FDA approval · 2018-10-23
  FDA Approved: NAPROXEN SODIUM PM — Original Application (Strategic Sourcing Services LLC)

  FDA approved Naproxen Sodium PM, a combination of naproxen sodium and diphenhydramine, under an Original Application by Strategic Sourcing S…

• FDA approval · 2018-09-28
  FDA Approved: OXYMORPHONE HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  The FDA approved a supplemental application for Oxymorphone hydrochloride from Amneal Pharmaceuticals of New York LLC (ANDA 079087).

• FDA approval · 2018-09-26
  FDA Approved: BUTALBITAL, ACETAMINOPHEN AND CAFFEINE — Original Application (Aurolife Pharma, LLC)

  FDA approved a generic tablet containing butalbital, acetaminophen, and caffeine under ANDA204733 (Original Application) for Aurolife Pharma…

• FDA approval · 2018-09-21
  FDA Approved: TRAMADOL HYDROCHLORIDE — Supplemental Application (Lupin Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for tramadol hydrochloride by Lupin Pharmaceuticals, authorizing its marketing as a generic anal…

• FDA approval · 2018-09-21
  FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc., granting approval for this generic …

• FDA approval · 2018-09-21
  FDA Approved: PENTAZOCINE AND NALOXONE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for Pentazocine and Naloxone from Actavis Pharma, authorizing a generic pentazocine/naloxone com…

• FDA approval · 2018-09-21
  FDA Approved: HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Supplemental Application (Eywa Pharma Inc)

  FDA approved Eywa Pharma Inc's supplemental application for hydrocodone bitartrate and acetaminophen, a combination analgesic. The approval …