Details for New Drug Application (NDA): 209506
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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 209506
Tradename: | DAPSONE |
Applicant: | Taro |
Ingredient: | dapsone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 209506
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DAPSONE | dapsone | GEL;TOPICAL | 209506 | ANDA | NORTHSTAR RX LLC | 16714-956 | 16714-956-01 | 1 TUBE in 1 CARTON (16714-956-01) / 60 g in 1 TUBE |
DAPSONE | dapsone | GEL;TOPICAL | 209506 | ANDA | NORTHSTAR RX LLC | 16714-956 | 16714-956-02 | 1 TUBE in 1 CARTON (16714-956-02) / 90 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 5% | ||||
Approval Date: | Oct 16, 2017 | TE: | AB | RLD: | No |
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