Details for New Drug Application (NDA): 212701
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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: 212701
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DAPSONE | dapsone | GEL;TOPICAL | 212701 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1627 | 69238-1627-6 | 1 BOTTLE, PUMP in 1 CARTON (69238-1627-6) / 60 g in 1 BOTTLE, PUMP |
DAPSONE | dapsone | GEL;TOPICAL | 212701 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1627 | 69238-1627-9 | 1 BOTTLE, PUMP in 1 CARTON (69238-1627-9) / 90 g in 1 BOTTLE, PUMP |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 7.5% | ||||
Approval Date: | May 31, 2023 | TE: | AB | RLD: | No |
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