Details for New Drug Application (NDA): 207165
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The generic ingredient in DAPSONE is dapsone. There are eight drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the dapsone profile page.
Suppliers and Packaging for NDA: 207165
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DAPSONE | dapsone | TABLET;ORAL | 207165 | ANDA | Rising Pharma Holdings, Inc. | 64980-566 | 64980-566-01 | 100 TABLET in 1 BOTTLE (64980-566-01) |
DAPSONE | dapsone | TABLET;ORAL | 207165 | ANDA | Rising Pharma Holdings, Inc. | 64980-566 | 64980-566-03 | 30 TABLET in 1 BOTTLE (64980-566-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | May 8, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | Jul 20, 2023 | TE: | AB | RLD: | No |
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