DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 078116
The generic ingredient in RISPERIDONE is risperidone. There are thirty drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the risperidone profile page.
Summary for 078116
Tradename: | RISPERIDONE |
Applicant: | Sandoz |
Ingredient: | risperidone |
Patents: | 0 |
Therapeutic Class: | Antipsychotics Bipolar Agents |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 078116
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RISPERIDONE | risperidone | TABLET, ORALLY DISINTEGRATING;ORAL | 078116 | ANDA | Sandoz Inc | 0781-5310 | N | 0781-5310-08 |
RISPERIDONE | risperidone | TABLET, ORALLY DISINTEGRATING;ORAL | 078116 | ANDA | Sandoz Inc | 0781-5311 | N | 0781-5311-08 |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 0.5MG | ||||
Approval Date: | Dec 22, 2009 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 1MG | ||||
Approval Date: | Dec 22, 2009 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 2MG | ||||
Approval Date: | Dec 22, 2009 | TE: | AB | RLD: | No |
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