Details for New Drug Application (NDA): 040502
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The generic ingredient in PYRIDOSTIGMINE BROMIDE is pyridostigmine bromide. There are eleven drug master file entries for this compound. Twenty-two 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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