Details for New Drug Application (NDA): 078452
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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 078452
Tradename: | RISPERIDONE |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | risperidone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 078452
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RISPERIDONE | risperidone | SOLUTION;ORAL | 078452 | ANDA | Aurobindo Pharma Limited | 65862-167 | 65862-167-01 | 1 BOTTLE in 1 CARTON (65862-167-01) / 30 mL in 1 BOTTLE |
RISPERIDONE | risperidone | SOLUTION;ORAL | 078452 | ANDA | Aurobindo Pharma Limited | 65862-167 | 65862-167-30 | 1 BOTTLE, GLASS in 1 CARTON (65862-167-30) / 30 mL in 1 BOTTLE, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 1MG/ML | ||||
Approval Date: | Sep 4, 2009 | TE: | AA | RLD: | No |
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