Details for New Drug Application (NDA): 204074
✉ Email this page to a colleague
NDA 204074 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 204074
| Tradename: | DAPSONE |
| Applicant: | Chartwell Rx |
| Ingredient: | dapsone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 204074
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DAPSONE | dapsone | TABLET;ORAL | 204074 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-222 | 43353-222-30 | 30 TABLET in 1 BOTTLE (43353-222-30) |
| DAPSONE | dapsone | TABLET;ORAL | 204074 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-223 | 43353-223-30 | 30 TABLET in 1 BOTTLE (43353-223-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | May 10, 2016 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | May 10, 2016 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
