Details for New Drug Application (NDA): 215091
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NDA 215091 describes ALLOPURINOL, which is a drug marketed by Accord Hlthcare, Aiping Pharm Inc, Aurobindo Pharma Ltd, Chartwell, Harman Finochem, Hetero Labs Ltd V, Ipca Labs Ltd, Lupin, Mutual Pharm, Mylan, Northstar Hlthcare, Ph Health, Puracap Pharm, Purepac Pharm, Regcon Holdings, Sandoz, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, Unichem, Watson Labs, Zydus Pharms, Gland, and Hikma, and is included in thirty-one NDAs. It is available from forty suppliers. Additional details are available on the ALLOPURINOL profile page.
The generic ingredient in ALLOPURINOL is allopurinol sodium. There are 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 ALLOPURINOL is allopurinol sodium. There are 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 215091
| Tradename: | ALLOPURINOL |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | allopurinol |
| Patents: | 0 |
Pharmacology for NDA: 215091
| Mechanism of Action | Xanthine Oxidase Inhibitors |
Medical Subject Heading (MeSH) Categories for 215091
Suppliers and Packaging for NDA: 215091
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ALLOPURINOL | allopurinol | TABLET;ORAL | 215091 | ANDA | Aurobindo Pharma Limited | 59651-285 | 59651-285-01 | 100 TABLET in 1 BOTTLE (59651-285-01) |
| ALLOPURINOL | allopurinol | TABLET;ORAL | 215091 | ANDA | Aurobindo Pharma Limited | 59651-285 | 59651-285-99 | 1000 TABLET in 1 BOTTLE (59651-285-99) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Apr 14, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 300MG | ||||
| Approval Date: | Apr 14, 2025 | TE: | AB | RLD: | No | ||||
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