Details for New Drug Application (NDA): 210158
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NDA 210158 describes DALFAMPRIDINE, which is a drug marketed by Accord Hlthcare, Actavis Labs Fl Inc, Alkem Labs Ltd, Aurobindo Pharma, Hikma, Micro Labs, Rising, and Sun Pharm, and is included in eight NDAs. It is available from eight suppliers. Additional details are available on the DALFAMPRIDINE profile page.
The generic ingredient in DALFAMPRIDINE is dalfampridine. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the dalfampridine profile page.
The generic ingredient in DALFAMPRIDINE is dalfampridine. There are ten drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the dalfampridine profile page.
Summary for 210158
| Tradename: | DALFAMPRIDINE |
| Applicant: | Micro Labs |
| Ingredient: | dalfampridine |
| Patents: | 0 |
Pharmacology for NDA: 210158
| Mechanism of Action | Potassium Channel Antagonists |
Suppliers and Packaging for NDA: 210158
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DALFAMPRIDINE | dalfampridine | TABLET, EXTENDED RELEASE;ORAL | 210158 | ANDA | Micro Labs Limited | 42571-275 | 42571-275-05 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-05) |
| DALFAMPRIDINE | dalfampridine | TABLET, EXTENDED RELEASE;ORAL | 210158 | ANDA | Micro Labs Limited | 42571-275 | 42571-275-10 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (42571-275-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 10MG | ||||
| Approval Date: | Mar 11, 2019 | TE: | AB | RLD: | No | ||||
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