Myasthenia Gravis
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Sign up freeTop drugs studied for this disease
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FDA approval · 2022-11-16FDA Approved: NEOSTIGMINE METHYLSULFATE — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved a supplemental ANDA for Neostigmine methylsulfate by Amneal Pharmaceuticals LLC.
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FDA approval · 2022-06-08FDA Approved: NEOSTIGMINE METHYLSULFATE — Supplemental Application (Civica, Inc.)
The FDA approved a supplemental application for Neostigmine methylsulfate filed by Civica, Inc. This approval covers the drug under the term…
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FDA approval · 2022-06-08FDA Approved: NEOSTIGMINE — Supplemental Application (Dr.Reddy's Laboratories Inc)
FDA approved Dr. Reddy's Laboratories' supplemental application for neostigmine (generic) under the ANDA program. This action records an app…
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FDA approval · 2022-05-31FDA Approved: NEOSTIGMINE METHYLSULFATE — Supplemental Application (Par Health USA, LLC)
FDA approved a supplemental application for Neostigmine Methylsulfate submitted by Par Health USA, LLC.
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FDA approval · 2022-05-10FDA Approved: NEOSTIGMINE METHYLSULFATE — Supplemental Application (BE Pharmaceuticals Inc.)
The FDA approved a supplemental application for NEOSTIGMINE METHYLSULFATE from BE Pharmaceuticals Inc., updating the approved product.
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FDA approval · 2022-05-05FDA Approved: NEOSTIGMINE METHYLSULFATE — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA approved a supplemental application for neostigmine methylsulfate from Amneal Pharmaceuticals LLC.
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FDA approval · 2022-04-19FDA Approved: PYRIDOSTIGMINE BROMIDE — Original Application (Acella Pharmaceuticals, LLC)
FDA approved the original application for pyridostigmine bromide as a generic product developed by Acella Pharmaceuticals, LLC.
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FDA approval · 2021-12-17FDA Approved: VYVGART — Original Application (argenx US)
The FDA approved VYVGART (efgartigimod alfa) in its original application for the treatment of generalized myasthenia gravis.
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FDA approval · 2021-10-01FDA Approved: NEOSTIGMINE METHYLSULFATE — Original Application (Indoco Remedies Limited)
FDA approved the original application for NEOSTIGMINE METHYLSULFATE from Indoco Remedies Limited (ANDA210652). The approval supports its use…
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FDA approval · 2021-04-20FDA Approved: NEOSTIGMINE METHYLSULFATE — Original Application (Somerset Therapeutics, LLC)
The FDA approved a generic version of neostigmine methylsulfate through an original ANDA by Somerset Therapeutics, LLC. It is indicated for …
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FDA approval · 2021-04-05FDA Approved: REGONOL — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for REGONOL (pyridostigmine bromide) filed by Sandoz Inc.
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FDA approval · 2021-04-05FDA Approved: NEOSTIGMINE METHYLSULFATE — Original Application (Meitheal Pharmaceuticals Inc.)
The FDA approved a generic version of neostigmine methylsulfate from Meitheal Pharmaceuticals Inc. for its approved uses in treating myasthe…
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FDA approval · 2021-02-04FDA Approved: NEOSTIGMINE METHYLSULFATE — Supplemental Application (Fresenius Kabi USA, LLC)
FDA approved a supplemental application for Neostigmine methylsulfate submitted by Fresenius Kabi USA, LLC. The approval updates the product…
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FDA approval · 2021-01-19FDA Approved: BLOXIVERZ — Supplemental Application (Exela Pharma Sciences, LLC)
FDA approved a supplemental application for BLOXIVERZ (neostigmine methylsulfate) submitted by Exela Pharma Sciences, LLC.
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FDA approval · 2020-01-10FDA Approved: PYRIDOSTIGMINE BROMIDE — Original Application (Amneal Pharmaceuticals NY LLC)
FDA approves the original application for pyridostigmine bromide by Amneal Pharmaceuticals NY LLC.
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FDA approval · 2020-01-09FDA Approved: PRYIDOSTIGMINE BROMIDE — Original Application (Apnar Pharma LP)
FDA approved an original application for pyridostigmine bromide from Apnar Pharma LP, establishing a generic version of the drug. The approv…
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FDA approval · 2019-10-29FDA Approved: PYRIDOSTIGMINE BROMIDE — Supplemental Application (Oceanside Pharmaceuticals)
FDA approved a supplemental application for pyridostigmine bromide submitted by Oceanside Pharmaceuticals.
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FDA approval · 2019-10-16FDA Approved: NEOSTIGMINE METHYLSULFATE — Original Application (Gland Pharma Limited)
FDA approved NEOSTIGMINE METHYLSULFATE from Gland Pharma Limited under an original application.
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FDA approval · 2019-05-13FDA Approved: NEOSTIGMINE METHYLSULFATE — Original Application (BE Pharmaceuticals Inc.)
FDA approved the original application for Neostigmine methylsulfate from BE Pharmaceuticals Inc., authorizing a generic version of this drug…
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FDA approval · 2019-03-08FDA Approved: PYRIDOSTIGMINE — Original Application (Novitium Pharma LLC)
FDA approved pyridostigmine bromide oral from Novitium Pharma LLC under an Original Application (ANDA 211694).
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FDA approval · 2018-07-20FDA Approved: PYRIDOSTIGMINE BROMIDE — Original Application (Method Pharmaceuticals, LLC)
The FDA approved an original application for pyridostigmine bromide by Method Pharmaceuticals LLC, adding a generic version of the cholinest…
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FDA approval · 2018-07-10FDA Approved: NEOSTIGMINE — Original Application (Dr.Reddy's Laboratories Inc)
FDA approved Dr. Reddy's Laboratories' original application for neostigmine, a generic acetylcholinesterase inhibitor used to treat myasthen…
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FDA approval · 2018-06-15FDA Approved: NEOSTIGMINE METHYLSULFATE — Original Application (Amneal Pharmaceuticals LLC)
FDA approval of a generic neostigmine methylsulfate product (ANDA) by Amneal Pharmaceuticals LLC.
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FDA approval · 2017-09-25FDA Approved: NEOSTIGMINE METHYLSULFATE — Original Application (Amphastar Pharmaceuticals, Inc.)
FDA approved Amphastar Pharmaceuticals' neostigmine methylsulfate as an original ANDA (ANDA209933) for indications including treatment of my…
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FDA approval · 2017-08-15FDA Approved: PYRIDOSTIGMINE BROMIDE — Original Application (Rising Pharma Holdings, Inc.)
FDA approves a generic pyridostigmine bromide product under an Original Application (ANDA205464). The indication is treatment of myasthenia …