Details for New Drug Application (NDA): 218021
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NDA 218021 describes HYDROXYUREA, which is a drug marketed by Barr, Barr Labs Inc, Leading, Ph Health, Qilu, and Roxane, and is included in seven NDAs. It is available from ten suppliers. Additional details are available on the HYDROXYUREA profile page.
The generic ingredient in HYDROXYUREA is hydroxyurea. There are ten drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the hydroxyurea profile page.
The generic ingredient in HYDROXYUREA is hydroxyurea. There are ten drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the hydroxyurea profile page.
Summary for 218021
| Tradename: | HYDROXYUREA |
| Applicant: | Qilu |
| Ingredient: | hydroxyurea |
| Patents: | 0 |
Suppliers and Packaging for NDA: 218021
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROXYUREA | hydroxyurea | CAPSULE;ORAL | 218021 | ANDA | Coupler LLC | 67046-1619 | 67046-1619-3 | 30 CAPSULE in 1 BLISTER PACK (67046-1619-3) |
| HYDROXYUREA | hydroxyurea | CAPSULE;ORAL | 218021 | ANDA | Qilu Pharmaceutical Co., Ltd. | 67184-0607 | 67184-0607-1 | 100 CAPSULE in 1 BOTTLE (67184-0607-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 500MG | ||||
| Approval Date: | Mar 6, 2024 | TE: | AB | RLD: | No | ||||
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