Details for New Drug Application (NDA): 040512
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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 040512
Tradename: | PYRIDOSTIGMINE BROMIDE |
Applicant: | Ani Pharms |
Ingredient: | pyridostigmine bromide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 040512
Mechanism of Action | Cholinesterase Inhibitors |
Medical Subject Heading (MeSH) Categories for 040512
Suppliers and Packaging for NDA: 040512
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PYRIDOSTIGMINE BROMIDE | pyridostigmine bromide | TABLET;ORAL | 040512 | ANDA | ANI Pharmaceuticals, Inc. | 62559-470 | 62559-470-01 | 100 TABLET in 1 BOTTLE (62559-470-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 60MG | ||||
Approval Date: | Oct 8, 2003 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
Approval Date: | Jul 20, 2005 | TE: | RLD: | No |
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