Details for New Drug Application (NDA): 214722
✉ Email this page to a colleague
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 214722
Tradename: | DAPSONE |
Applicant: | Torrent |
Ingredient: | dapsone |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 214722
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DAPSONE | dapsone | GEL;TOPICAL | 214722 | ANDA | Torrent Pharmaceuticals Limited | 13668-605 | 13668-605-05 | 1 BOTTLE, PUMP in 1 CARTON (13668-605-05) / 60 g in 1 BOTTLE, PUMP |
DAPSONE | dapsone | GEL;TOPICAL | 214722 | ANDA | Torrent Pharmaceuticals Limited | 13668-605 | 13668-605-08 | 1 BOTTLE, PUMP in 1 CARTON (13668-605-08) / 90 g in 1 BOTTLE, PUMP |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GEL;TOPICAL | Strength | 7.5% | ||||
Approval Date: | Feb 10, 2022 | TE: | AB | RLD: | No |
Complete Access Available with Subscription