Orange Book product · Brand (NDA)
DROXIA
HYDROXYUREA
At a glance
Feb 25, 1998
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 25, 1998
28 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
HYDROXYUREA
Strength
200MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 016295
Product number
002
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2024XROMIBrand (NDA)
NDA 216593 · NOVA LABS LTD
- 2017SIKLOSBrand (NDA)
NDA 208843 · THERAVIA
- 2024HYDROXYUREAGeneric (ANDA)
ANDA 218021 · QILU
- 2020HYDROXYUREAGeneric (ANDA)
ANDA 213438 · LEADING
- 2000HYDROXYUREAGeneric (ANDA)
ANDA 075143 · BARR
- 2000HYDROXYUREAGeneric (ANDA)
ANDA 075734 · BARR
- 2000HYDROXYUREAGeneric (ANDA)
ANDA 075020 · BARR LABS INC
- 1999HYDROXYUREAGeneric (ANDA)
ANDA 075340 · PH HEALTH
- 1995HYDROXYUREAGeneric (ANDA)
ANDA 074476 · ROXANE
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
