Details for New Drug Application (NDA): 212363
✉ Email this page to a colleague
NDA 212363 describes ALLOPURINOL SODIUM, which is a drug marketed by Gland Pharma Ltd and Hikma and is included in two NDAs. It is available from three suppliers. Additional details are available on the ALLOPURINOL SODIUM profile page.
The generic ingredient in ALLOPURINOL SODIUM is allopurinol sodium. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the allopurinol sodium profile page.
The generic ingredient in ALLOPURINOL SODIUM is allopurinol sodium. There are twenty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the allopurinol sodium profile page.
Summary for 212363
| Tradename: | ALLOPURINOL SODIUM |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | allopurinol sodium |
| Patents: | 0 |
Pharmacology for NDA: 212363
| Mechanism of Action | Xanthine Oxidase Inhibitors |
Suppliers and Packaging for NDA: 212363
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALLOPURINOL SODIUM | allopurinol sodium | INJECTABLE;INJECTION | 212363 | ANDA | Fresenius Kabi USA, LLC | 65219-380 | 65219-380-30 | 1 VIAL, GLASS in 1 CARTON (65219-380-30) / 25 mL in 1 VIAL, GLASS |
| ALLOPURINOL SODIUM | allopurinol sodium | INJECTABLE;INJECTION | 212363 | ANDA | Gland Pharma Limited | 68083-380 | 68083-380-01 | 1 VIAL, GLASS in 1 CARTON (68083-380-01) / 25 mL in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG BASE/VIAL | ||||
| Approval Date: | Jan 26, 2022 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
