Details for New Drug Application (NDA): 020298
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NDA 020298 describes ALOPRIM, which is a drug marketed by Mylan and is included in one NDA. It is available from one supplier. Additional details are available on the ALOPRIM profile page.
The generic ingredient in ALOPRIM is allopurinol sodium. There are twenty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the allopurinol sodium profile page.
The generic ingredient in ALOPRIM is allopurinol sodium. There are twenty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the allopurinol sodium profile page.
Summary for 020298
| Tradename: | ALOPRIM |
| Applicant: | Mylan |
| Ingredient: | allopurinol sodium |
| Patents: | 0 |
Pharmacology for NDA: 020298
| Mechanism of Action | Xanthine Oxidase Inhibitors |
Suppliers and Packaging for NDA: 020298
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALOPRIM | allopurinol sodium | INJECTABLE;INJECTION | 020298 | NDA | Mylan Institutional LLC | 67457-187 | 67457-187-50 | 1 VIAL, GLASS in 1 CARTON (67457-187-50) / 25 mL in 1 VIAL, GLASS |
| ALOPRIM | allopurinol sodium | INJECTABLE;INJECTION | 020298 | NDA | Mylan Institutional LLC | 67457-978 | 67457-978-50 | 1 VIAL, GLASS in 1 CARTON (67457-978-50) / 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: | May 17, 1996 | TE: | AP | RLD: | Yes | ||||
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