Details for New Drug Application (NDA): 212405
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NDA 212405 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 twenty suppliers. There are eight patents protecting this drug. Additional details are available on the PYRIDOSTIGMINE BROMIDE profile page.
The generic ingredient in PYRIDOSTIGMINE BROMIDE is pyridostigmine bromide. There are eleven drug master file entries for this compound. Twenty-three 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 are eleven drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the pyridostigmine bromide profile page.
Summary for 212405
| Tradename: | PYRIDOSTIGMINE BROMIDE |
| Applicant: | Milla Pharms |
| Ingredient: | pyridostigmine bromide |
| Patents: | 0 |
Pharmacology for NDA: 212405
| Mechanism of Action | Cholinesterase Inhibitors |
Medical Subject Heading (MeSH) Categories for 212405
Suppliers and Packaging for NDA: 212405
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PYRIDOSTIGMINE BROMIDE | pyridostigmine bromide | SYRUP;ORAL | 212405 | ANDA | Acella Pharmaceuticals, LLC | 42192-626 | 42192-626-16 | 473 mL in 1 BOTTLE (42192-626-16) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 60MG/5ML | ||||
| Approval Date: | Apr 19, 2022 | TE: | AA | RLD: | No | ||||
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