Details for New Drug Application (NDA): 016295
✉ Email this page to a colleague
The generic ingredient in HYDREA 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 016295
Tradename: | HYDREA |
Applicant: | Cheplapharm |
Ingredient: | hydroxyurea |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 016295
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DROXIA | hydroxyurea | CAPSULE;ORAL | 016295 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-0830 | 0003-0830-50 | 100 CAPSULE in 1 BOTTLE (0003-0830-50) |
DROXIA | hydroxyurea | CAPSULE;ORAL | 016295 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-6335 | 0003-6335-17 | 60 CAPSULE in 1 BOTTLE (0003-6335-17) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 500MG | ||||
Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 200MG | ||||
Approval Date: | Feb 25, 1998 | TE: | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 300MG | ||||
Approval Date: | Feb 25, 1998 | TE: | RLD: | Yes |
Expired US Patents for NDA 016295
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Cheplapharm | HYDREA | hydroxyurea | CAPSULE;ORAL | 016295-001 | Approved Prior to Jan 1, 1982 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription