Details for New Drug Application (NDA): 075020
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NDA 075020 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 075020
| Tradename: | HYDROXYUREA |
| Applicant: | Barr Labs Inc |
| Ingredient: | hydroxyurea |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 075020
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 500MG | ||||
| Approval Date: | Jul 30, 1998 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 250MG | ||||
| Approval Date: | Jun 26, 2000 | TE: | RLD: | No | |||||
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