Details for New Drug Application (NDA): 214019
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The generic ingredient in DAPSONE is dapsone. There are eight drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the dapsone profile page.
Summary for 214019
Tradename: | DAPSONE |
Applicant: | Zydus |
Ingredient: | dapsone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 214019
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DAPSONE | dapsone | GEL;TOPICAL | 214019 | ANDA | Zydus Lifesciences Limited | 70771-1538 | 70771-1538-2 | 1 BOTTLE, PUMP in 1 CARTON (70771-1538-2) / 30 g in 1 BOTTLE, PUMP |
DAPSONE | dapsone | GEL;TOPICAL | 214019 | ANDA | Zydus Lifesciences Limited | 70771-1538 | 70771-1538-3 | 1 BOTTLE, PUMP in 1 CARTON (70771-1538-3) / 60 g in 1 BOTTLE, PUMP |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 7.5% | ||||
Approval Date: | May 8, 2024 | TE: | AB | RLD: | No |
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