Details for New Drug Application (NDA): 075340
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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 075340
Tradename: | HYDROXYUREA |
Applicant: | Endo Operations |
Ingredient: | hydroxyurea |
Patents: | 0 |
Suppliers and Packaging for NDA: 075340
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
HYDROXYUREA | hydroxyurea | CAPSULE;ORAL | 075340 | ANDA | Major Pharmaceuticals | 0904-6939 | 0904-6939-61 | 100 BLISTER PACK in 1 CARTON (0904-6939-61) / 1 CAPSULE in 1 BLISTER PACK |
HYDROXYUREA | hydroxyurea | CAPSULE;ORAL | 075340 | ANDA | Endo USA, Inc. | 49884-724 | 49884-724-01 | 100 CAPSULE in 1 BOTTLE (49884-724-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 500MG | ||||
Approval Date: | Feb 24, 1999 | TE: | AB | RLD: | No |
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