Orange Book product · Brand (NDA)
TEMODAR
TEMOZOLOMIDE
At a glance
Feb 27, 2009
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 27, 2009
17 yr 7 mo ago
Today
Pharmaceutical detail
Active ingredient
TEMOZOLOMIDE
Strength
100MG/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 022277
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.
- 1999TEMODARBrand (NDA)
NDA 021029 · 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.
