Details for New Drug Application (NDA): 208228
✉ Email this page to a colleague
NDA 208228 describes VILAZODONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Alembic, Apotex, Invagen Pharms, and Teva Pharms Usa, and is included in five NDAs. It is available from eleven suppliers. Additional details are available on the VILAZODONE HYDROCHLORIDE profile page.
The generic ingredient in VILAZODONE HYDROCHLORIDE is vilazodone hydrochloride. There are fourteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the vilazodone hydrochloride profile page.
The generic ingredient in VILAZODONE HYDROCHLORIDE is vilazodone hydrochloride. There are fourteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the vilazodone hydrochloride profile page.
Summary for 208228
| Tradename: | VILAZODONE HYDROCHLORIDE |
| Applicant: | Apotex |
| Ingredient: | vilazodone hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 208228
Suppliers and Packaging for NDA: 208228
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VILAZODONE HYDROCHLORIDE | vilazodone hydrochloride | TABLET;ORAL | 208228 | ANDA | Apotex Corp. | 60505-4372 | 60505-4372-3 | 30 TABLET in 1 BOTTLE (60505-4372-3) |
| VILAZODONE HYDROCHLORIDE | vilazodone hydrochloride | TABLET;ORAL | 208228 | ANDA | Apotex Corp. | 60505-4373 | 60505-4373-3 | 30 TABLET in 1 BOTTLE (60505-4373-3) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Jul 7, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Jul 7, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | Jul 7, 2023 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
