Details for New Drug Application (NDA): 077494
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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 077494
Tradename: | RISPERIDONE |
Applicant: | Endo Operations |
Ingredient: | risperidone |
Patents: | 0 |
Suppliers and Packaging for NDA: 077494
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RISPERIDONE | risperidone | TABLET, ORALLY DISINTEGRATING;ORAL | 077494 | ANDA | ENDO USA, Inc. | 49884-212 | 49884-212-55 | 5 BLISTER PACK in 1 CARTON (49884-212-55) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (49884-212-52) |
RISPERIDONE | risperidone | TABLET, ORALLY DISINTEGRATING;ORAL | 077494 | ANDA | ENDO USA, Inc. | 49884-311 | 49884-311-55 | 5 BLISTER PACK in 1 CARTON (49884-311-55) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 0.25MG | ||||
Approval Date: | Apr 30, 2009 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 0.5MG | ||||
Approval Date: | Apr 30, 2009 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 1MG | ||||
Approval Date: | Oct 26, 2009 | TE: | AB | RLD: | No |
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