Orange Book product · Brand (NDA)
CLIGAVYX
FULVESTRANT
At a glance
Aug 19, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 19, 2019
6 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
FULVESTRANT
Strength
250MG/5ML (50MG/ML)
Dosage form
SOLUTION
Route
INTRAMUSCULAR
TE code
Not listed
Application
NDA 210063
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 2019FULVESTRANTBrand (NDA)
NDA 210326 · FRESENIUS KABI USA
- 2002FASLODEXBrand (NDA)
NDA 021344 · ASTRAZENECA
- 2023FULVESTRANTGeneric (ANDA)
ANDA 215169 · EUGIA PHARMA
- 2022FULVESTRANTGeneric (ANDA)
ANDA 215077 · ALEMBIC
- 2022FULVESTRANTGeneric (ANDA)
ANDA 214682 · JIANGSU HANSOH PHARM
- 2021FULVESTRANTGeneric (ANDA)
ANDA 213553 · XIROMED
- 2021FULVESTRANTGeneric (ANDA)
ANDA 215234 · ZYDUS PHARMS
- 2021FULVESTRANTGeneric (ANDA)
ANDA 211730 · APOTEX
- 2020FULVESTRANTGeneric (ANDA)
ANDA 211689 · ACCORD HLTHCARE
- 2020FULVESTRANTGeneric (ANDA)
ANDA 209246 · DR REDDYS
- 2020FULVESTRANTGeneric (ANDA)
ANDA 211422 · CHIA TAI TIANQING
- 2019FULVESTRANTGeneric (ANDA)
ANDA 209714 · HBT LABS INC
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.
