Details for New Drug Application (NDA): 214019
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NDA 214019 describes DAPSONE, which is a drug marketed by Alembic, Amneal, Cosette, Encube, Mylan, Padagis Israel, Taro, Torrent, Trupharma, Zydus Lifesciences, Actavis Llc, Alvogen, Chartwell Rx, Everest Life Sci, Nostrum Labs Inc, Novitium Pharma, and Rising, and is included in twenty-three NDAs. It is available from twenty-four suppliers. Additional details are available on the DAPSONE profile page.
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.
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.
Summary for 214019
| Tradename: | DAPSONE |
| Applicant: | Zydus Lifesciences |
| Ingredient: | dapsone |
| Patents: | 0 |
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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