Details for New Drug Application (NDA): 040502
NDA 040502 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 040502
| Tradename: | PYRIDOSTIGMINE BROMIDE |
| Applicant: | Impax Labs |
| Ingredient: | pyridostigmine bromide |
| Patents: | 0 |
Pharmacology for NDA: 040502
| Mechanism of Action | Cholinesterase Inhibitors |
Medical Subject Heading (MeSH) Categories for 040502
Suppliers and Packaging for NDA: 040502
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PYRIDOSTIGMINE BROMIDE | pyridostigmine bromide | TABLET;ORAL | 040502 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-2134 | 0115-2134-01 | 21 TABLET in 1 BOTTLE (0115-2134-01) |
| PYRIDOSTIGMINE BROMIDE | pyridostigmine bromide | TABLET;ORAL | 040502 | ANDA | Amneal Pharmaceuticals of New York LLC | 0115-3511 | 0115-3511-01 | 100 TABLET in 1 BOTTLE (0115-3511-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
| Approval Date: | Apr 24, 2003 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
| Approval Date: | Jun 28, 2022 | TE: | AB | RLD: | No | ||||
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