Pain
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FDA approval · 2014-08-19FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
The FDA approved a supplemental application from VistaPharm, LLC for methadone hydrochloride, updating an existing ANDA product.
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FDA approval · 2014-08-19FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc. under an ANDA.
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FDA approval · 2014-08-19FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc., authorizing the generic product…
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FDA approval · 2014-08-19FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for Methadone Hydrochloride from Ascend Laboratories, LLC, confirming approval of a generic methadon…
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FDA approval · 2014-08-19FDA Approved: OXYCONTIN — Supplemental Application (Purdue Pharma LP)
The FDA approved a supplemental application for OxyContin (oxycodone hydrochloride) submitted by Purdue Pharma LP.
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FDA approval · 2014-08-19FDA Approved: BUTRANS — Supplemental Application (Purdue Pharma LP)
FDA approved a supplemental application for BUTRANS (buprenorphine transdermal patch) submitted by Purdue Pharma LP.
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FDA approval · 2014-08-19FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
The FDA approved a supplemental application for methadone hydrochloride by VistaPharm, LLC under ANDA090707, enabling a generic methadone hy…
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FDA approval · 2014-08-19FDA Approved: OXYMORPHONE HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for Oxymorphone hydrochloride from Amneal Pharmaceuticals of New York LLC.
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FDA approval · 2014-08-19FDA Approved: MORPHINE SULFATE EXTENDED RELEASE — Supplemental Application (Rhodes Pharmaceuticals L. P.)
FDA approved a supplemental application for Morphine Sulfate Extended Release (Morphine Sulfate) from Rhodes Pharmaceuticals L.P., under an …
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FDA approval · 2014-08-19FDA Approved: MORPHINE SULFATE EXTENDED RELEASE — Supplemental Application (Rhodes Pharmaceuticals L. P.)
FDA approved a supplemental application for Morphine Sulfate Extended Release from Rhodes Pharmaceuticals L. P., updating the product's stat…
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FDA approval · 2014-08-19FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
The FDA approved a supplemental application for methadone hydrochloride from SpecGx LLC for this generic product.
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FDA approval · 2014-07-23FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for methadone hydrochloride submitted by SpecGx LLC (ANDA 040517). The action represents approval of…
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FDA approval · 2014-07-23FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Ascend Laboratories, LLC)
The FDA approved a supplemental ANDA for Ascend Laboratories' methadone hydrochloride, a generic opioid product.
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FDA approval · 2014-06-16FDA Approved: FENTANYL TRANSDERMAL — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for fentanyl transdermal submitted by SpecGx LLC, resulting in a regulatory update for the product.
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FDA approval · 2014-04-21FDA Approved: SPRIX — Supplemental Application (Zyla Life Sciences US LLC)
The FDA approved a supplemental application for SPRIX (ketorolac tromethamine) by Zyla Life Sciences US LLC, expanding its approved uses.
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FDA approval · 2014-04-16FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (VistaPharm, LLC)
The FDA approved a supplemental application for methadone hydrochloride submitted by VistaPharm, LLC.
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FDA approval · 2014-04-16FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for methadone hydrochloride from Hikma Pharmaceuticals USA Inc., approving a generic version of this…
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FDA approval · 2014-04-16FDA Approved: BUTRANS — Supplemental Application (Purdue Pharma LP)
FDA has approved a supplemental application for BUTRANS (buprenorphine) submitted by Purdue Pharma LP.
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FDA approval · 2014-04-16FDA Approved: OXYMORPHONE HYDROCHLORIDE — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
The FDA approved a supplemental ANDA for a generic oxymorphone hydrochloride product from Amneal Pharmaceuticals of New York LLC for the man…
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FDA approval · 2014-04-16FDA Approved: TAPENTADOL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved Hikma Pharmaceuticals USA Inc.'s supplemental application for tapentadol hydrochloride (generic tapentadol), authorizing its ma…
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FDA approval · 2014-04-16FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for methadone hydrochloride submitted by Hikma Pharmaceuticals USA Inc.
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FDA approval · 2014-02-04FDA Approved: OXYCONTIN — Supplemental Application (Purdue Pharma LP)
FDA approved a supplemental application for OXYCONTIN (oxycodone hydrochloride) submitted by Purdue Pharma LP.
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FDA approval · 2014-01-16FDA Approved: TAPENTADOL — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Tapentadol hydrochloride (generic) submitted by Hikma Pharmaceuticals USA Inc.
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FDA approval · 2013-10-18FDA Approved: OXYCODONE AND ACETAMINOPHEN — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for a generic oxycodone/acetaminophen product from Amneal Pharmaceuticals of New York LLC.
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FDA approval · 2013-10-18FDA Approved: HYDROCODONE BITARTRATE AND ACETAMINOPHEN — Supplemental Application (Genus Lifesciences Inc.)
The FDA approved a supplemental application from Genus Lifesciences Inc. for hydrocodone bitartrate and acetaminophen, enabling a generic ve…