Details for New Drug Application (NDA): 211694
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NDA 211694 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 211694
| Tradename: | PYRIDOSTIGMINE BROMIDE |
| Applicant: | Novitium Pharma |
| Ingredient: | pyridostigmine bromide |
| Patents: | 0 |
Pharmacology for NDA: 211694
| Mechanism of Action | Cholinesterase Inhibitors |
Medical Subject Heading (MeSH) Categories for 211694
Suppliers and Packaging for NDA: 211694
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PYRIDOSTIGMINE BROMIDE | pyridostigmine bromide | SYRUP;ORAL | 211694 | ANDA | VistaPharm, LLC | 66689-406 | 66689-406-10 | 1 TRAY in 1 CASE (66689-406-10) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (66689-406-01) |
| PYRIDOSTIGMINE BROMIDE | pyridostigmine bromide | SYRUP;ORAL | 211694 | ANDA | Novitium Pharma LLC | 70954-148 | 70954-148-10 | 473 mL in 1 BOTTLE (70954-148-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SYRUP;ORAL | Strength | 60MG/5ML | ||||
| Approval Date: | Mar 8, 2019 | TE: | AA | RLD: | No | ||||
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