Details for New Drug Application (NDA): 213374
✉ Email this page to a colleague
The generic ingredient in DEFERASIROX is deferasirox. There are twenty drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the deferasirox profile page.
Summary for 213374
Tradename: | DEFERASIROX |
Applicant: | Alkem Labs Ltd |
Ingredient: | deferasirox |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 213374
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEFERASIROX | deferasirox | GRANULE;ORAL | 213374 | ANDA | Ascend Laboratories, LLC | 67877-675 | 67877-675-84 | 30 PACKET in 1 CARTON (67877-675-84) / 1 GRANULE in 1 PACKET (67877-675-71) |
DEFERASIROX | deferasirox | GRANULE;ORAL | 213374 | ANDA | Ascend Laboratories, LLC | 67877-676 | 67877-676-84 | 30 PACKET in 1 CARTON (67877-676-84) / 1 GRANULE in 1 PACKET (67877-676-72) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE;ORAL | Strength | 90MG | ||||
Approval Date: | Jul 14, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE;ORAL | Strength | 180MG | ||||
Approval Date: | Jul 14, 2020 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE;ORAL | Strength | 360MG | ||||
Approval Date: | Jul 14, 2020 | TE: | AB | RLD: | No |
Complete Access Available with Subscription