Details for New Drug Application (NDA): 204737
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NDA 204737 describes PYRIDOSTIGMINE BROMIDE, which is a drug marketed by Amneal, Milla Pharms, MSN, Novitium Pharma, Rising, Alvogen, Impax Labs Inc, Ani Pharms, Eywa, Impax Labs, Solvay, Us Army, and Zydus Pharms, and is included in fifteen NDAs. It is available from nineteen suppliers. 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-two 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-two suppliers are listed for this compound. Additional details are available on the pyridostigmine bromide profile page.
Summary for 204737
| Tradename: | PYRIDOSTIGMINE BROMIDE |
| Applicant: | Alvogen |
| Ingredient: | pyridostigmine bromide |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 204737
| Mechanism of Action | Cholinesterase Inhibitors |
Medical Subject Heading (MeSH) Categories for 204737
Suppliers and Packaging for NDA: 204737
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PYRIDOSTIGMINE BROMIDE | pyridostigmine bromide | TABLET, EXTENDED RELEASE;ORAL | 204737 | ANDA | Alvogen, Inc. | 47781-335 | 47781-335-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (47781-335-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 180MG | ||||
| Approval Date: | Jun 26, 2015 | TE: | AB | RLD: | No | ||||
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