Orange Book product · Generic (ANDA)
HYDROXYUREA
HYDROXYUREA
At a glance
Apr 08, 2020
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 08, 2020
6 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
HYDROXYUREA
Strength
500MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 213438
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of HYDROXYUREA
- 2024XROMIBrand (NDA)
NDA 216593 · NOVA LABS LTD
- 2017SIKLOSBrand (NDA)
NDA 208843 · THERAVIA
- 1998DROXIABrand (NDA)
NDA 016295 · WAYLIS THERAP
- 2024HYDROXYUREAGeneric (ANDA)
ANDA 218021 · QILU
- 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.
