Details for New Drug Application (NDA): 201003
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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 201003
Tradename: | RISPERIDONE |
Applicant: | Ajanta Pharma Ltd |
Ingredient: | risperidone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 201003
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RISPERIDONE | risperidone | TABLET;ORAL | 201003 | ANDA | Ajanta Pharma USA Inc. | 27241-001 | 27241-001-06 | 60 TABLET in 1 BOTTLE (27241-001-06) |
RISPERIDONE | risperidone | TABLET;ORAL | 201003 | ANDA | Ajanta Pharma USA Inc. | 27241-001 | 27241-001-50 | 500 TABLET in 1 BOTTLE (27241-001-50) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.25MG | ||||
Approval Date: | Aug 24, 2011 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
Approval Date: | Aug 24, 2011 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Aug 24, 2011 | TE: | AB | RLD: | No |
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