Orange Book product · Brand (NDA)
TEMODAR
TEMOZOLOMIDE
At a glance
Aug 11, 1999
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 11, 1999
27 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
TEMOZOLOMIDE
Strength
20MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 021029
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.
- 2009TEMODARBrand (NDA)
NDA 022277 · MERCK SHARP DOHME
- 2024TEMOZOLOMIDEGeneric (ANDA)
ANDA 210030 · HETERO LABS LTD V
- 2021TEMOZOLOMIDEGeneric (ANDA)
ANDA 213328 · NIVAGEN PHARMS INC
- 2018TEMOZOLOMIDEGeneric (ANDA)
ANDA 204159 · APOTEX
- 2017TEMOZOLOMIDEGeneric (ANDA)
ANDA 206750 · ZYDUS PHARMS
- 2017TEMOZOLOMIDEGeneric (ANDA)
ANDA 207658 · DEVA HOLDING AS
- 2017TEMOZOLOMIDEGeneric (ANDA)
ANDA 203959 · WATSON LABS TEVA
- 2017TEMOZOLOMIDEGeneric (ANDA)
ANDA 201528 · ACCORD HLTHCARE
- 2016TEMOZOLOMIDEGeneric (ANDA)
ANDA 204639 · CHEMI SPA
- 2016TEMOZOLOMIDEGeneric (ANDA)
ANDA 203490 · ANI PHARMS
- 2016TEMOZOLOMIDEGeneric (ANDA)
ANDA 205227 · EXTROVIS
- 2016TEMOZOLOMIDEGeneric (ANDA)
ANDA 206309 · RISING
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.
