Details for New Drug Application (NDA): 077542
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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 077542
Tradename: | RISPERIDONE |
Applicant: | Sun Pharm Inds Ltd |
Ingredient: | risperidone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 077542
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
RISPERIDONE | risperidone | TABLET, ORALLY DISINTEGRATING;ORAL | 077542 | ANDA | Sun Pharmaceutical Industries, Inc. | 63304-949 | 63304-949-05 | 500 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (63304-949-05) |
RISPERIDONE | risperidone | TABLET, ORALLY DISINTEGRATING;ORAL | 077542 | ANDA | Sun Pharmaceutical Industries, Inc. | 63304-949 | 63304-949-17 | 10 POUCH in 1 BOX, UNIT-DOSE (63304-949-17) / 1 TABLET, ORALLY DISINTEGRATING in 1 POUCH (63304-949-11) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 0.5MG | ||||
Approval Date: | Aug 6, 2010 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 1MG | ||||
Approval Date: | Aug 6, 2010 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, ORALLY DISINTEGRATING;ORAL | Strength | 2MG | ||||
Approval Date: | Aug 6, 2010 | TE: | AB | RLD: | No |
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