Details for New Drug Application (NDA): 216229
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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 216229
Tradename: | DEFERASIROX |
Applicant: | Annora Pharma |
Ingredient: | deferasirox |
Patents: | 0 |
Suppliers and Packaging for NDA: 216229
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DEFERASIROX | deferasirox | GRANULE;ORAL | 216229 | ANDA | Camber Pharmaceuticals, Inc. | 31722-029 | 31722-029-32 | 30 PACKET in 1 CARTON (31722-029-32) / 1 GRANULE in 1 PACKET |
DEFERASIROX | deferasirox | GRANULE;ORAL | 216229 | ANDA | Camber Pharmaceuticals, Inc. | 31722-030 | 31722-030-32 | 30 PACKET in 1 CARTON (31722-030-32) / 1 GRANULE in 1 PACKET |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE;ORAL | Strength | 180MG | ||||
Approval Date: | Sep 22, 2022 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE;ORAL | Strength | 360MG | ||||
Approval Date: | Sep 22, 2022 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | GRANULE;ORAL | Strength | 90MG | ||||
Approval Date: | Mar 16, 2023 | TE: | AB | RLD: | No |
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