Details for New Drug Application (NDA): 213438
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NDA 213438 describes HYDROXYUREA, which is a drug marketed by Barr, Barr Labs Inc, Endo Operations, Leading, Qilu, and Roxane, and is included in seven NDAs. It is available from twelve 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. Sixteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the hydroxyurea profile page.
Summary for 213438
| Tradename: | HYDROXYUREA |
| Applicant: | Leading |
| Ingredient: | hydroxyurea |
| Patents: | 0 |
Suppliers and Packaging for NDA: 213438
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HYDROXYUREA | hydroxyurea | CAPSULE;ORAL | 213438 | ANDA | Marlex Pharmaceuticals, Inc. | 10135-702 | 10135-702-01 | 100 CAPSULE in 1 BOTTLE, PLASTIC (10135-702-01) |
| HYDROXYUREA | hydroxyurea | CAPSULE;ORAL | 213438 | ANDA | Golden State Medical Supply, Inc. | 51407-909 | 51407-909-01 | 100 CAPSULE in 1 BOTTLE, PLASTIC (51407-909-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 500MG | ||||
| Approval Date: | Apr 8, 2020 | TE: | AB | RLD: | No | ||||
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