Pain
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FDA approval · 2021-06-02FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Camber Pharmaceuticals, Inc)
The FDA approved a supplemental application for methadone hydrochloride from Camber Pharmaceuticals, Inc., confirming approval for this gene…
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FDA approval · 2021-06-02FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for methadone hydrochloride from SpecGx LLC, confirming approval of a generic methadone hydrochlorid…
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FDA approval · 2021-06-02FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc. (ANDA 087393), granting approval of …
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FDA approval · 2021-06-02FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Aurolife Pharma, LLC)
The FDA approved a supplemental application for methadone hydrochloride from Aurolife Pharma, LLC, enabling the generic product to be market…
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FDA approval · 2021-06-02FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
FDA approved a supplemental application for methadone hydrochloride (generic methadone) submitted by VistaPharm, LLC under ANDA204166.
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FDA approval · 2021-06-02FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Methadone Hydrochloride (generic) submitted by Hikma Pharmaceuticals USA Inc.
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FDA approval · 2021-05-06FDA Approved: MITIGO — Supplemental Application (Piramal Critical Care, Inc.)
FDA approved a supplemental submission for MITIGO (morphine sulfate) by Piramal Critical Care, Inc., approving changes to an existing morphi…
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FDA approval · 2021-04-28FDA Approved: KETOROLAC TROMETHAMINE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical Industries' supplemental application for ketorolac tromethamine.
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FDA approval · 2021-04-28FDA Approved: ETODOLAC — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Etodolac submitted by Zydus Pharmaceuticals USA Inc.
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FDA approval · 2021-04-28FDA Approved: KETOROLAC TROMETHAMINE — Supplemental Application (FOSUN PHARMA USA INC)
FDA approved a supplemental application for ketorolac tromethamine from Fosun Pharma USA Inc, under the ANDA pathway.
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FDA approval · 2021-04-28FDA Approved: BUPRENORPHINE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
FDA approved a supplemental application for buprenorphine from Teva Pharmaceuticals USA, Inc. under ANDA204937.
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FDA approval · 2021-04-26FDA Approved: ETODOLAC — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for Etodolac from Zydus Pharmaceuticals USA Inc.
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FDA approval · 2021-03-05FDA Approved: BUTORPHANOL TARTRATE — Supplemental Application (Apotex Corp.)
The FDA approved a supplemental application for butorphanol tartrate from Apotex Corp., updating the product labeling.
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FDA approval · 2021-03-04FDA Approved: HYDROMORPHONE HYDROCHLORIDE — Supplemental Application (Padagis US LLC)
FDA approved a supplemental application for Hydromorphone Hydrochloride from Padagis US LLC. The supplemental approval pertains to a generic…
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FDA approval · 2021-03-04FDA Approved: HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
The FDA approved a supplemental application to market a hydrocodone bitartrate and acetaminophen combination product from Amneal Pharmaceuti…
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FDA approval · 2021-03-04FDA Approved: HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved a supplemental application for Hydrocodone Bitartrate and Acetaminophen from Amneal Pharmaceuticals LLC under the ANDA process.
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FDA approval · 2021-03-04FDA Approved: ACETAMINOPHEN AND CODEINE PHOSPHATE — Supplemental Application (Strides Pharma Science Limited)
FDA approved a supplemental application for Acetaminophen and Codeine Phosphate from Strides Pharma Science Limited under the approved ANDA.…
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FDA approval · 2021-03-04FDA Approved: MS CONTIN — Supplemental Application (Rhodes Pharmaceuticals L.P.)
FDA approved a supplemental application for MS CONTIN (morphine sulfate) by Rhodes Pharmaceuticals L.P.
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FDA approval · 2021-03-04FDA Approved: OXYCODONE AND ACETAMINOPHEN — Supplemental Application (SpecGx LLC)
FDA approved SpecGx LLC's supplemental application for a generic oxycodone hydrochloride and acetaminophen product (Oxycodone and acetaminop…
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FDA approval · 2021-03-04FDA Approved: OXYCODONE AND ACETAMINOPHEN — Supplemental Application (FH2 Pharma LLC)
FDA approved FH2 Pharma LLC's supplemental application for OXYCODONE AND ACETAMINOPHEN tablets, enabling its marketing as a generic product …
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FDA approval · 2021-03-04FDA Approved: TAPENTADOL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for tapentadol hydrochloride (brand Tapentadol) submitted by Hikma Pharmaceuticals USA Inc.
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FDA approval · 2021-03-04FDA Approved: ROXICODONE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for Roxicodone (oxycodone hydrochloride) submitted by SpecGx LLC.
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FDA approval · 2021-03-04FDA Approved: HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for HYDROCODONE BITARTRATE AND ACETAMINOPHEN from Hikma Pharmaceuticals USA Inc., indicating an appr…
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FDA approval · 2021-03-04FDA Approved: TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE — Supplemental Application (Trigen Laboratories, LLC)
The FDA approved a supplemental NDA for tramadol hydrochloride extended-release submitted by Trigen Laboratories, LLC, resulting in approval…
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FDA approval · 2021-03-04FDA Approved: OXYMORPHONE HYDROCHLORIDE — Supplemental Application (Epic Pharma, LLC)
FDA approved Epic Pharma's supplemental application for oxymorphone hydrochloride, authorizing the generic product as an analgesic for pain …