Details for New Drug Application (NDA): 202386
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The generic ingredient in RISPERIDONE is risperidone. There are thirty drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the risperidone profile page.
Summary for 202386
Tradename: | RISPERIDONE |
Applicant: | Chartwell Molecular |
Ingredient: | risperidone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 202386
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RISPERIDONE | risperidone | SOLUTION;ORAL | 202386 | ANDA | Chartwell RX, LLC | 62135-929 | 62135-929-43 | 30 mL in 1 BOTTLE (62135-929-43) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 1MG/ML | ||||
Approval Date: | Jan 12, 2015 | TE: | AA | RLD: | No |
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