Orange Book product · Generic (ANDA)
TEMOZOLOMIDE
TEMOZOLOMIDE
At a glance
Apr 26, 2017
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 26, 2017
9 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
TEMOZOLOMIDE
Strength
5MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 207658
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of TEMOZOLOMIDE
- 2009TEMODARBrand (NDA)
NDA 022277 · MERCK SHARP DOHME
- 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 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.
