Details for New Drug Application (NDA): 213907
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The generic ingredient in DAPSONE is dapsone. There are eight drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the dapsone profile page.
Summary for 213907
Tradename: | DAPSONE |
Applicant: | Beloteca |
Ingredient: | dapsone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 213907
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DAPSONE | dapsone | GEL;TOPICAL | 213907 | ANDA | Trupharma, LLC | 52817-831 | 52817-831-60 | 1 TUBE in 1 CARTON (52817-831-60) / 60 g in 1 TUBE |
DAPSONE | dapsone | GEL;TOPICAL | 213907 | ANDA | Trupharma, LLC | 52817-831 | 52817-831-90 | 1 TUBE in 1 CARTON (52817-831-90) / 90 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 5% | ||||
Approval Date: | Jun 6, 2023 | TE: | AB | RLD: | No |
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