Details for New Drug Application (NDA): 078516
✉ Email this page to a colleague
The generic ingredient in RISPERIDONE is risperidone. There are thirty drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the risperidone profile page.
Summary for 078516
Tradename: | RISPERIDONE |
Applicant: | Zydus Pharms Usa |
Ingredient: | risperidone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 078516
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RISPERIDONE | risperidone | TABLET, ORALLY DISINTEGRATING;ORAL | 078516 | ANDA | Zydus Lifesciences Limited | 65841-640 | 65841-640-06 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65841-640-06) |
RISPERIDONE | risperidone | TABLET, ORALLY DISINTEGRATING;ORAL | 078516 | ANDA | Zydus Lifesciences Limited | 65841-641 | 65841-641-06 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (65841-641-06) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 0.5MG | ||||
Approval Date: | May 1, 2009 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 2MG | ||||
Approval Date: | May 1, 2009 | TE: | AB | RLD: | No |
Complete Access Available with Subscription