Details for New Drug Application (NDA): 211181
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NDA 211181 describes PYRIDOSTIGMINE BROMIDE, which is a drug marketed by Amneal, Milla Pharms, MSN, Novitium Pharma, Rising, Alvogen, Impax Labs Inc, Ani Pharms, Impax Labs, MLV, Solvay, Us Army, and Zydus Pharms, and is included in sixteen NDAs. It is available from eighteen suppliers. There are nine patents protecting this drug. Additional details are available on the PYRIDOSTIGMINE BROMIDE profile page.
The generic ingredient in PYRIDOSTIGMINE BROMIDE is pyridostigmine bromide. There is one drug master file entry for this compound. Twenty suppliers are listed for this compound. Additional details are available on the pyridostigmine bromide profile page.
The generic ingredient in PYRIDOSTIGMINE BROMIDE is pyridostigmine bromide. There is one drug master file entry for this compound. Twenty suppliers are listed for this compound. Additional details are available on the pyridostigmine bromide profile page.
Summary for 211181
| Tradename: | PYRIDOSTIGMINE BROMIDE |
| Applicant: | Mlv |
| Ingredient: | pyridostigmine bromide |
| Patents: | 0 |
Pharmacology for NDA: 211181
| Mechanism of Action | Cholinesterase Inhibitors |
Medical Subject Heading (MeSH) Categories for 211181
Suppliers and Packaging for NDA: 211181
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PYRIDOSTIGMINE BROMIDE | pyridostigmine bromide | TABLET;ORAL | 211181 | ANDA | Method Pharmaceuticals, LLC | 58657-810 | 58657-810-21 | 21 TABLET in 1 BOTTLE (58657-810-21) |
| PYRIDOSTIGMINE BROMIDE | pyridostigmine bromide | TABLET;ORAL | 211181 | ANDA | Method Pharmaceuticals, LLC | 58657-811 | 58657-811-01 | 100 TABLET in 1 BOTTLE (58657-811-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
| Approval Date: | Jul 20, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
| Approval Date: | May 14, 2019 | TE: | AB | RLD: | No | ||||
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