Headache
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-05-09FDA Approved: ASCOMP WITH CODEINE — Supplemental Application (LGM PHARMA SOLUTIONS, LLC)
The FDA approved a supplemental application for ASCOMP WITH CODEINE, a combination product of butalbital, aspirin, caffeine, and codeine pho…
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FDA approval · 2025-01-21FDA Approved: BUTALBITAL, ASPIRIN, AND CAFFEINE — Supplemental Application (LGM PHARMA SOLUTIONS, LLC)
The FDA approved a supplemental application for the generic fixed-dose combination of butalbital, aspirin, and caffeine. The product is manu…
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FDA approval · 2024-11-21FDA Approved: BUTALBITAL, ASPIRIN, AND CAFFEINE — Supplemental Application (Lannett Company, Inc.)
The FDA approved a supplemental ANDA from Lannett Company to market a generic Butalbital, Aspirin, and Caffeine product.
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FDA approval · 2024-11-21FDA Approved: BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE — Supplemental Application (Amneal Pharmaceuticals of New York, LLC)
FDA granted supplemental approval for Amneal's generic product containing butalbital, aspirin, caffeine, and codeine phosphate.
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FDA approval · 2024-11-21FDA Approved: IBUPROFEN — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved a supplemental application for ibuprofen from Actavis Pharma, Inc.
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FDA approval · 2023-12-15FDA Approved: BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE — Supplemental Application (Amneal Pharmaceuticals of New York, LLC)
The FDA approved a supplemental application for Amneal's fixed-dose combination product of butalbital, aspirin, caffeine and codeine phospha…
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FDA approval · 2022-05-31FDA Approved: IBUPROFEN PM — Original Application (KROGER COMPANY)
FDA approved Kroger's Ibuprofen PM, an over-the-counter combination product containing ibuprofen and diphenhydramine citrate, under an origi…
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FDA approval · 2020-10-28FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)
FDA approved a supplemental application to add Aleve GelCaps (naproxen sodium) as a new gelcap dosage form for naproxen sodium, expanding th…
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FDA approval · 2020-05-08FDA Approved: IBUPROFEN — Original Application (Aurobindo Pharma Limited)
FDA approved Aurobindo Pharma Limited's ibuprofen generic under Original Application (ANDA213794). The product is a generic version of ibupr…
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FDA approval · 2019-07-22FDA Approved: IBUPROFEN — Supplemental Application (Chartwell RX, LLC)
The FDA approved a supplemental application for ibuprofen from Chartwell RX, LLC under ANDA 202413, authorizing the specified changes to thi…
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FDA approval · 2019-07-22FDA Approved: IBUPROFEN — Supplemental Application (Amneal Pharmaceuticals of New York LLC)
FDA approved a supplemental application for ibuprofen by Amneal Pharmaceuticals of New York LLC.
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FDA approval · 2018-12-28FDA Approved: BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE — Supplemental Application (LGM PHARMA SOLUTIONS, LLC)
The FDA approved a supplemental application for the generic combination product butalbital, acetaminophen, and caffeine from LGM PHARMA SOLU…
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FDA approval · 2018-10-31FDA Approved: BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE — Original Application (LGM PHARMA SOLUTIONS, LLC)
FDA approved a generic version of the combination analgesic butalbital, acetaminophen, and caffeine for headache indications.
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FDA approval · 2018-09-26FDA 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…
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FDA approval · 2017-12-01FDA Approved: IBUPROFEN AND PSEUDOEPHEDRINE HCL — Original Application (Aurohealth LLC)
FDA approved Aurohealth LLC's ibuprofen and pseudoephedrine HCl combination as an Original Application. It is an over-the-counter product in…
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FDA approval · 2016-12-16FDA Approved: BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE — Supplemental Application (Actavis Pharma, Inc.)
FDA approved a supplemental application for the combination analgesic Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate (Actavis), …
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FDA approval · 2016-03-18FDA Approved: NAPROXEN SODIUM HEADACHE PAIN — Original Application (Aurohealth LLC)
FDA approved the original ANDA for Naproxen Sodium Headache Pain, a generic naproxen product manufactured by Aurohealth LLC.
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FDA approval · 2016-03-15FDA Approved: ADVIL PM- DIPHENHYDRAMINE CITRATE AND IBUPROFEN TABLET, COATED — Supplemental Application (Lil Drug Store Products, Inc)
FDA approved a supplemental application for Advil PM tablets (ibuprofen and diphenhydramine citrate), expanding labeling to include this com…
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FDA approval · 2016-02-08FDA Approved: IBUPROFEN — Supplemental Application (TIME CAP LABORATORIES,INC)
FDA approved a supplemental application for ibuprofen tablets from Time Cap Laboratories, Inc.
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FDA approval · 2015-10-28FDA Approved: ALEVE PM — Supplemental Application (Bayer HealthCare LLC.)
FDA approved a supplemental application for ALEVE PM (diphenhydramine hydrochloride and naproxen sodium) to support its continued marketing …
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FDA approval · 2015-08-14FDA Approved: ALEVE PM — Supplemental Application (Bayer HealthCare LLC.)
FDA approved a supplemental application for Aleve PM, a diphenhydramine HCl and naproxen sodium combination from Bayer HealthCare LLC. The a…
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FDA approval · 2015-07-31FDA Approved: BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE — Supplemental Application (Actavis Pharma, Inc.)
The FDA approved a supplemental application for the combination drug Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate from Actavis…
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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 · 2014-12-12FDA Approved: DG HEALTH MIGRAINE RELIEF — Supplemental Application (Dolgencorp, LLC)
FDA approved a supplemental application for Dolgencorp's DG Health Migraine Relief, authorizing the approval of a combination analgesic cont…
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FDA approval · 2013-04-18FDA Approved: ALEVE GELCAPS — Supplemental Application (Bayer HealthCare LLC.)
FDA approves a supplemental application for Aleve GelCaps to expand labeling for naproxen sodium, broadening indications for pain relief.