Details for New Drug Application (NDA): 208200
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NDA 208200 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 208200
| Tradename: | VILAZODONE HYDROCHLORIDE |
| Applicant: | Invagen Pharms |
| Ingredient: | vilazodone hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 208200
Suppliers and Packaging for NDA: 208200
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VILAZODONE HYDROCHLORIDE | vilazodone hydrochloride | TABLET;ORAL | 208200 | ANDA | Cipla USA Inc. | 69097-979 | 69097-979-02 | 30 TABLET, FILM COATED in 1 BOTTLE (69097-979-02) |
| VILAZODONE HYDROCHLORIDE | vilazodone hydrochloride | TABLET;ORAL | 208200 | ANDA | Cipla USA Inc. | 69097-981 | 69097-981-02 | 30 TABLET, FILM COATED in 1 BOTTLE (69097-981-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Apr 7, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 40MG | ||||
| Approval Date: | Apr 7, 2021 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 20MG | ||||
| Approval Date: | Dec 6, 2022 | TE: | AB | RLD: | No | ||||
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