Details for New Drug Application (NDA): 214068
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The generic ingredient in RISPERIDONE is risperidone. There are thirty drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the risperidone profile page.
Summary for 214068
Tradename: | RISPERIDONE |
Applicant: | Teva Pharms Usa Inc |
Ingredient: | risperidone |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 214068
Suppliers and Packaging for NDA: 214068
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RISPERIDONE | risperidone | INJECTABLE;INTRAMUSCULAR | 214068 | ANDA | Teva Pharmaceuticals, Inc. | 0480-1232 | 0480-1232-08 | 1 KIT in 1 CARTON (0480-1232-08) * 2 mL in 1 VIAL (0480-9733-01) * 2 mL in 1 SYRINGE (0480-1200-21) |
RISPERIDONE | risperidone | INJECTABLE;INTRAMUSCULAR | 214068 | ANDA | Teva Pharmaceuticals, Inc. | 0480-1342 | 0480-1342-08 | 1 KIT in 1 CARTON (0480-1342-08) * 2 mL in 1 VIAL (0480-9734-01) * 2 mL in 1 SYRINGE (0480-1200-21) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAMUSCULAR | Strength | 12.5MG/VIAL | ||||
Approval Date: | Dec 5, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAMUSCULAR | Strength | 25MG/VIAL | ||||
Approval Date: | Dec 5, 2023 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAMUSCULAR | Strength | 37.5MG/VIAL | ||||
Approval Date: | Dec 5, 2023 | TE: | AB | RLD: | No |
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