Orange Book product · Brand (NDA)
SIKLOS
HYDROXYUREA
At a glance
Dec 21, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 21, 2017
8 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
HYDROXYUREA
Strength
1GM
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 208843
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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
- 1998DROXIABrand (NDA)
NDA 016295 · WAYLIS THERAP
- 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.
