Pain
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Sign up freeTop drugs studied for this disease
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FDA approval · 2015-06-26FDA Approved: HYDROMORPHONE HYDROCHLORIDE — Supplemental Application (Padagis US LLC)
FDA approved a supplemental application for Hydromorphone Hydrochloride from Padagis US LLC under ANDA 204278. Hydromorphone hydrochloride i…
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FDA approval · 2015-06-26FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for methadone hydrochloride from SpecGx LLC, enabling the marketing of a generic methadone hydrochlo…
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FDA approval · 2015-06-26FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
The FDA approved a supplemental application for Methadone Hydrochloride from Hikma Pharmaceuticals USA Inc., enabling a generic methadone hy…
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FDA approval · 2015-06-26FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)
FDA approved a supplemental application for Methadone Hydrochloride by Hikma Pharmaceuticals USA Inc., authorizing a change to the approved …
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FDA approval · 2015-06-26FDA Approved: FENTANYL TRANSDERMAL — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for fentanyl transdermal submitted by SpecGx LLC.
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FDA approval · 2015-06-26FDA Approved: FENTANYL — Supplemental Application (Aveva Drug Delivery Systems Inc.)
FDA approved a supplemental application for fentanyl submitted by Aveva Drug Delivery Systems Inc., under ANDA 077449.
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FDA approval · 2015-06-11FDA Approved: FENTANYL TRANSDERMAL — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for Fentanyl Transdermal filed by SpecGx LLC.
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FDA approval · 2015-06-10FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Original Application (Advagen Pharma Ltd)
FDA approved Advagen Pharma Ltd's original application for buprenorphine hydrochloride, authorizing a generic product of buprenorphine for a…
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FDA approval · 2015-06-04FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for methadone hydrochloride (generic methadone HCl) from Ascend Laboratories, LLC. The approval cove…
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FDA approval · 2015-06-01FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for methadone hydrochloride from SpecGx LLC under an ANDA, indicating an updated/added approval for …
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FDA approval · 2015-04-16FDA 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…
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FDA approval · 2015-04-07FDA Approved: ADVIL PM- DIPHENHYDRAMINE CITRATE AND IBUPROFEN TABLET, COATED — Supplemental Application (Lil Drug Store Products, Inc)
The FDA approved a supplemental NDA for Advil PM comprising ibuprofen and diphenhydramine citrate tablets (coated) from Lil Drug Store Produ…
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FDA approval · 2015-02-25FDA Approved: ALEVE PM — Supplemental Application (Bayer HealthCare LLC.)
The FDA approved a supplemental application for Aleve PM (diphenhydramine hydrochloride and naproxen sodium) from Bayer HealthCare LLC. The …
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FDA approval · 2015-02-12FDA Approved: BUPRENORPHINE HYDROCHLORIDE — Supplemental Application (PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma)
FDA approved a supplemental application for a generic buprenorphine hydrochloride product (ANDA 090622) from PAI Holdings/PAI Pharma.
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FDA approval · 2015-01-20FDA Approved: TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE — Supplemental Application (Trigen Laboratories, LLC)
FDA approved a supplemental application for TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE, authorizing its continued marketing as an extended-rele…
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FDA approval · 2015-01-05FDA Approved: TRAMADOL HYDROCHLORIDE EXTENDED-RELEASE — Supplemental Application (Trigen Laboratories, LLC)
FDA approved a supplemental application for tramadol hydrochloride extended-release, confirming regulatory approval for an extended-release …
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FDA approval · 2014-12-15FDA Approved: OXYMORPHONE HYDROCHLORIDE — Original Application (Epic Pharma, LLC)
The FDA approved Epic Pharma, LLC's abbreviated new drug application for Oxymorphone Hydrochloride, enabling a generic opioid analgesic prod…
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FDA approval · 2014-12-13FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
The FDA approved a supplemental application for methadone hydrochloride manufactured by SpecGx LLC. This approval confirms the continued sta…
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FDA approval · 2014-12-13FDA Approved: METHADOSE DISPERSIBLE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for METHADOSE DISPERSIBLE, a dispersible methadone hydrochloride product filed by SpecGx LLC.
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FDA approval · 2014-11-21FDA Approved: HYDROMET — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for HYDROMET (hydrocodone bitartrate and homatropine methylbromide) from Actavis Pharma, Inc.
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FDA approval · 2014-11-05FDA Approved: METHADONE HYDROCHLORIDE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for methadone hydrochloride submitted by SpecGx LLC, granting supplemental approval for a generic pr…
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FDA approval · 2014-10-22FDA Approved: OXYCONTIN — Supplemental Application (Purdue Pharma LP)
FDA approved a supplemental application for OxyContin (oxycodone hydrochloride) from Purdue Pharma LP.
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FDA approval · 2014-09-25FDA Approved: PREMIER VALUE ARTHRITIS 8 HOUR — Supplemental Application (Premier Value)
FDA approved a supplemental application for Premier Value Arthritis 8 Hour Acetaminophen. The approval covers the generic acetaminophen tabl…
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FDA approval · 2014-09-22FDA Approved: METHADOSE — Supplemental Application (SpecGx LLC)
FDA approved a supplemental application for Methadose (methadone hydrochloride) submitted by SpecGx LLC.
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FDA approval · 2014-09-04FDA Approved: OXYCODONE HYDROCHLORIDE — Supplemental Application (Hikma Pharmceuticals USA Inc.)
The FDA approved a supplemental application for oxycodone hydrochloride from Hikma Pharmaceuticals USA Inc., updating the approval of this g…