Details for New Drug Application (NDA): 208937
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NDA 208937 describes TOLCAPONE, which is a drug marketed by Alvogen, Dr Reddys Labs Sa, Ingenus Pharms Llc, and Ph Health, and is included in four NDAs. It is available from one supplier. Additional details are available on the TOLCAPONE profile page.
The generic ingredient in TOLCAPONE is tolcapone. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the tolcapone profile page.
The generic ingredient in TOLCAPONE is tolcapone. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the tolcapone profile page.
Summary for 208937
| Tradename: | TOLCAPONE |
| Applicant: | Ingenus Pharms Llc |
| Ingredient: | tolcapone |
| Patents: | 0 |
Pharmacology for NDA: 208937
| Mechanism of Action | Catechol O-Methyltransferase Inhibitors |
Suppliers and Packaging for NDA: 208937
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TOLCAPONE | tolcapone | TABLET;ORAL | 208937 | ANDA | Ingenus Pharmaceuticals, LLC | 50742-193 | 50742-193-90 | 90 TABLET in 1 BOTTLE (50742-193-90) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Aug 7, 2018 | TE: | RLD: | No | |||||
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