Orange Book product · Brand (NDA)
FASLODEX
FULVESTRANT
At a glance
Apr 25, 2002
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 25, 2002
24 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
FULVESTRANT
Strength
125MG/2.5ML (50MG/ML)
Dosage form
SOLUTION
Route
INTRAMUSCULAR
TE code
Not listed
Application
NDA 021344
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.
- 2019CLIGAVYXBrand (NDA)
NDA 210063 · AVYXA HOLDINGS
- 2019FULVESTRANTBrand (NDA)
NDA 210326 · FRESENIUS KABI USA
- 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.
