Pain

• FDA approval · 2007-08-16
  FDA Approved: HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical's generic hydrocodone bitartrate and acetaminophen for relief of moderate to moderately severe acute pain. T…

• FDA approval · 2007-07-23
  FDA Approved: OXYCODONE AND ACETAMINOPHEN — Supplemental Application (SpecGx LLC)

  FDA approved a supplemental application for the fixed-dose combination of oxycodone hydrochloride and acetaminophen from SpecGx LLC.

• FDA approval · 2007-06-19
  FDA Approved: KETOROLAC TROMETHAMINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva's supplemental application for ketorolac tromethamine, a generic NSAID.

• FDA approval · 2007-06-07
  FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for generic methadone hydrochloride from Hikma Pharmaceuticals USA Inc.

• FDA approval · 2007-06-07
  FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Methadone Hydrochloride from Hikma Pharmaceuticals USA Inc., indicating approval of a generic pr…

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• FDA approval · 2007-05-11
  FDA Approved: MS CONTIN — Supplemental Application (Rhodes Pharmaceuticals L.P.)

  FDA approved a supplemental application for MS CONTIN (morphine sulfate) submitted by Rhodes Pharmaceuticals L.P.

• FDA approval · 2007-05-09
  FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  The FDA approved a supplemental application for methadone hydrochloride, a generic product manufactured by Hikma Pharmaceuticals USA Inc., u…

• FDA approval · 2007-04-18
  FDA Approved: PRIALT — Supplemental Application (TerSera Therapeutics LLC)

  FDA approved a supplemental application for PRIALT (ziconotide acetate) submitted by TerSera Therapeutics LLC.

• FDA approval · 2007-04-04
  FDA Approved: METHADOSE DISPERSIBLE — Supplemental Application (SpecGx LLC)

  FDA approved a supplemental application for METHADOSE DISPERSIBLE (methadone hydrochloride) by SpecGx LLC, introducing a dispersible formula…

• 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.

• FDA approval · 2007-02-06
  FDA Approved: KETOROLAC TROMETHAMINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for ketorolac tromethamine from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2007-01-23
  FDA Approved: FENTANYL — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA has approved a supplemental application for a fentanyl generic product from Mylan Pharmaceuticals Inc.

• FDA approval · 2007-01-10
  FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)

  FDA approved a supplemental application from SpecGx LLC for Methadone Hydrochloride (generic), confirming approval of a supplemental update …

• FDA approval · 2007-01-04
  FDA Approved: HYDROCODONE BITARTRATE AND IBUPROFEN — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for a generic hydrocodone bitartrate and ibuprofen product from Amneal Pharmaceuticals of New York L…

• FDA approval · 2006-12-07
  FDA Approved: DISKETS — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for DISKETS (methadone hydrochloride) submitted by Hikma Pharmaceuticals USA Inc.

• FDA approval · 2006-11-09
  FDA Approved: HYDROMORPHONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)

  FDA approved a supplemental application for Hydromorphone Hydrochloride from SpecGx LLC under an ANDA, indicating a change or addition to th…

• FDA approval · 2006-10-05
  FDA Approved: IBUPROFEN (NSAID) PAIN RELEIVER/ FEVER REDUCER — Supplemental Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved a supplemental application for Amneal's ibuprofen pain reliever/fever reducer, expanding/confirming its labeling and regulatory…

• FDA approval · 2006-09-20
  FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)

  FDA approved a supplemental application for methadone hydrochloride from SpecGx LLC.

• FDA approval · 2006-08-25
  FDA Approved: HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Original Application (Amneal Pharmaceuticals of New York LLC)

  FDA approved the original application for hydrocodone bitartrate and acetaminophen (generic) by Amneal Pharmaceuticals of New York LLC.

• FDA approval · 2006-08-25
  FDA Approved: HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Original Application (Amneal Pharmaceuticals LLC)

  FDA approves Amneal's generic hydrocodone bitartrate and acetaminophen tablets (hydrocodone/acetaminophen) under an Original Application for…