Details for New Drug Application (NDA): 203887
✉ Email this page to a colleague
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 203887
Tradename: | DAPSONE |
Applicant: | Nostrum Labs Inc |
Ingredient: | dapsone |
Patents: | 0 |
Suppliers and Packaging for NDA: 203887
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DAPSONE | dapsone | TABLET;ORAL | 203887 | ANDA | Nostrum Laboratories, Inc. | 29033-036 | 29033-036-01 | 100 TABLET in 1 BOTTLE (29033-036-01) |
DAPSONE | dapsone | TABLET;ORAL | 203887 | ANDA | Nostrum Laboratories, Inc. | 29033-036 | 29033-036-30 | 30 TABLET in 1 BOTTLE (29033-036-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
Approval Date: | May 6, 2016 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
Approval Date: | May 6, 2016 | TE: | AB | RLD: | No |
Complete Access Available with Subscription