Details for New Drug Application (NDA): 212405
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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 |
Formulation / Manufacturing: | see details |
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) |
PYRIDOSTIGMINE BROMIDE | pyridostigmine bromide | SYRUP;ORAL | 212405 | ANDA | Woodward Pharma Services LLC | 69784-130 | 69784-130-01 | 473 mL in 1 BOTTLE (69784-130-01) |
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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