Orange Book product · Brand (NDA)
CASODEX
BICALUTAMIDE
At a glance
Oct 04, 1995
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 04, 1995
31 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
BICALUTAMIDE
Strength
50MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 020498
Product number
001
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.
- 2015BICALUTAMIDEGeneric (ANDA)
ANDA 091011 · CHARTWELL RX
- 2015BICALUTAMIDEGeneric (ANDA)
ANDA 200274 · APOTEX
- 2011BICALUTAMIDEGeneric (ANDA)
ANDA 078285 · ROXANE
- 2010BICALUTAMIDEGeneric (ANDA)
ANDA 079045 · FRESENIUS KABI USA
- 2009BICALUTAMIDEGeneric (ANDA)
ANDA 078634 · WATSON LABS TEVA
- 2009BICALUTAMIDEGeneric (ANDA)
ANDA 078917 · ACCORD HLTHCARE
- 2009BICALUTAMIDEGeneric (ANDA)
ANDA 079089 · ADAPTIS
- 2009BICALUTAMIDEGeneric (ANDA)
ANDA 077995 · KUDCO IRELAND
- 2009BICALUTAMIDEGeneric (ANDA)
ANDA 079185 · RISING
- 2009BICALUTAMIDEGeneric (ANDA)
ANDA 078575 · SANDOZ
- 2009BICALUTAMIDEGeneric (ANDA)
ANDA 079110 · SUN PHARM
- 2009BICALUTAMIDEGeneric (ANDA)
ANDA 077973 · SYNTHON PHARMS
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.
