Details for New Drug Application (NDA): 075143
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The generic ingredient in HYDROXYUREA is hydroxyurea. There are ten drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the hydroxyurea profile page.
Summary for 075143
Tradename: | HYDROXYUREA |
Applicant: | Barr |
Ingredient: | hydroxyurea |
Patents: | 0 |
Suppliers and Packaging for NDA: 075143
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROXYUREA | hydroxyurea | CAPSULE;ORAL | 075143 | ANDA | Teva Pharmaceuticals USA, Inc. | 0555-0882 | 0555-0882-02 | 100 CAPSULE in 1 BOTTLE (0555-0882-02) |
HYDROXYUREA | hydroxyurea | CAPSULE;ORAL | 075143 | ANDA | AvKARE | 42291-321 | 42291-321-01 | 100 CAPSULE in 1 BOTTLE (42291-321-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 500MG | ||||
Approval Date: | Oct 16, 1998 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 250MG | ||||
Approval Date: | Sep 21, 2000 | TE: | RLD: | No |
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