Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 203490
Company: AMERIGEN PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TEMOZOLOMIDE TEMOZOLOMIDE 5MG CAPSULE;ORAL Prescription AB No No
TEMOZOLOMIDE TEMOZOLOMIDE 20MG CAPSULE;ORAL Prescription AB No No
TEMOZOLOMIDE TEMOZOLOMIDE 100MG CAPSULE;ORAL Prescription AB No No
TEMOZOLOMIDE TEMOZOLOMIDE 140MG CAPSULE;ORAL Prescription AB No No
TEMOZOLOMIDE TEMOZOLOMIDE 180MG CAPSULE;ORAL Prescription AB No No
TEMOZOLOMIDE TEMOZOLOMIDE 250MG CAPSULE;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/13/2016 ORIG-1 Approval

Label is not available on this site.

TEMOZOLOMIDE

CAPSULE;ORAL; 5MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TEMODAR TEMOZOLOMIDE 5MG CAPSULE;ORAL Prescription Yes AB 021029 MERCK SHARP DOHME
TEMOZOLOMIDE TEMOZOLOMIDE 5MG CAPSULE;ORAL Prescription No AB 201528 ACCORD HLTHCARE
TEMOZOLOMIDE TEMOZOLOMIDE 5MG CAPSULE;ORAL Prescription No AB 203490 AMERIGEN PHARMS LTD
TEMOZOLOMIDE TEMOZOLOMIDE 5MG CAPSULE;ORAL Prescription No AB 203691 AMNEAL PHARMS
TEMOZOLOMIDE TEMOZOLOMIDE 5MG CAPSULE;ORAL Prescription No AB 206309 ANDA REPOSITORY
TEMOZOLOMIDE TEMOZOLOMIDE 5MG CAPSULE;ORAL Prescription No AB 078879 BARR
TEMOZOLOMIDE TEMOZOLOMIDE 5MG CAPSULE;ORAL Prescription No AB 204639 CHEMI SPA
TEMOZOLOMIDE TEMOZOLOMIDE 5MG CAPSULE;ORAL Prescription No AB 207658 DEVA HOLDING AS
TEMOZOLOMIDE TEMOZOLOMIDE 5MG CAPSULE;ORAL Prescription No AB 206413 IDT AUSTRALIA LTD
TEMOZOLOMIDE TEMOZOLOMIDE 5MG CAPSULE;ORAL Prescription No AB 201742 SUN PHARM
TEMOZOLOMIDE TEMOZOLOMIDE 5MG CAPSULE;ORAL Prescription No AB 203959 WATSON LABS TEVA
TEMOZOLOMIDE TEMOZOLOMIDE 5MG CAPSULE;ORAL Prescription No AB 206750 ZYDUS PHARMS

CAPSULE;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TEMODAR TEMOZOLOMIDE 20MG CAPSULE;ORAL Prescription Yes AB 021029 MERCK SHARP DOHME
TEMOZOLOMIDE TEMOZOLOMIDE 20MG CAPSULE;ORAL Prescription No AB 201528 ACCORD HLTHCARE
TEMOZOLOMIDE TEMOZOLOMIDE 20MG CAPSULE;ORAL Prescription No AB 203490 AMERIGEN PHARMS LTD
TEMOZOLOMIDE TEMOZOLOMIDE 20MG CAPSULE;ORAL Prescription No AB 203691 AMNEAL PHARMS
TEMOZOLOMIDE TEMOZOLOMIDE 20MG CAPSULE;ORAL Prescription No AB 206309 ANDA REPOSITORY
TEMOZOLOMIDE TEMOZOLOMIDE 20MG CAPSULE;ORAL Prescription No AB 078879 BARR
TEMOZOLOMIDE TEMOZOLOMIDE 20MG CAPSULE;ORAL Prescription No AB 204639 CHEMI SPA
TEMOZOLOMIDE TEMOZOLOMIDE 20MG CAPSULE;ORAL Prescription No AB 207658 DEVA HOLDING AS
TEMOZOLOMIDE TEMOZOLOMIDE 20MG CAPSULE;ORAL Prescription No AB 206413 IDT AUSTRALIA LTD
TEMOZOLOMIDE TEMOZOLOMIDE 20MG CAPSULE;ORAL Prescription No AB 201742 SUN PHARM
TEMOZOLOMIDE TEMOZOLOMIDE 20MG CAPSULE;ORAL Prescription No AB 203959 WATSON LABS TEVA
TEMOZOLOMIDE TEMOZOLOMIDE 20MG CAPSULE;ORAL Prescription No AB 206750 ZYDUS PHARMS

CAPSULE;ORAL; 100MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TEMODAR TEMOZOLOMIDE 100MG CAPSULE;ORAL Prescription Yes AB 021029 MERCK SHARP DOHME
TEMOZOLOMIDE TEMOZOLOMIDE 100MG CAPSULE;ORAL Prescription No AB 201528 ACCORD HLTHCARE
TEMOZOLOMIDE TEMOZOLOMIDE 100MG CAPSULE;ORAL Prescription No AB 203490 AMERIGEN PHARMS LTD
TEMOZOLOMIDE TEMOZOLOMIDE 100MG CAPSULE;ORAL Prescription No AB 203691 AMNEAL PHARMS
TEMOZOLOMIDE TEMOZOLOMIDE 100MG CAPSULE;ORAL Prescription No AB 206309 ANDA REPOSITORY
TEMOZOLOMIDE TEMOZOLOMIDE 100MG CAPSULE;ORAL Prescription No AB 078879 BARR
TEMOZOLOMIDE TEMOZOLOMIDE 100MG CAPSULE;ORAL Prescription No AB 204639 CHEMI SPA
TEMOZOLOMIDE TEMOZOLOMIDE 100MG CAPSULE;ORAL Prescription No AB 207658 DEVA HOLDING AS
TEMOZOLOMIDE TEMOZOLOMIDE 100MG CAPSULE;ORAL Prescription No AB 206413 IDT AUSTRALIA LTD
TEMOZOLOMIDE TEMOZOLOMIDE 100MG CAPSULE;ORAL Prescription No AB 201742 SUN PHARM
TEMOZOLOMIDE TEMOZOLOMIDE 100MG CAPSULE;ORAL Prescription No AB 203959 WATSON LABS TEVA
TEMOZOLOMIDE TEMOZOLOMIDE 100MG CAPSULE;ORAL Prescription No AB 206750 ZYDUS PHARMS

CAPSULE;ORAL; 140MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TEMODAR TEMOZOLOMIDE 140MG CAPSULE;ORAL Prescription Yes AB 021029 MERCK SHARP DOHME
TEMOZOLOMIDE TEMOZOLOMIDE 140MG CAPSULE;ORAL Prescription No AB 201528 ACCORD HLTHCARE
TEMOZOLOMIDE TEMOZOLOMIDE 140MG CAPSULE;ORAL Prescription No AB 203490 AMERIGEN PHARMS LTD
TEMOZOLOMIDE TEMOZOLOMIDE 140MG CAPSULE;ORAL Prescription No AB 203691 AMNEAL PHARMS
TEMOZOLOMIDE TEMOZOLOMIDE 140MG CAPSULE;ORAL Prescription No AB 206309 ANDA REPOSITORY
TEMOZOLOMIDE TEMOZOLOMIDE 140MG CAPSULE;ORAL Prescription No AB 078879 BARR
TEMOZOLOMIDE TEMOZOLOMIDE 140MG CAPSULE;ORAL Prescription No AB 204639 CHEMI SPA
TEMOZOLOMIDE TEMOZOLOMIDE 140MG CAPSULE;ORAL Prescription No AB 207658 DEVA HOLDING AS
TEMOZOLOMIDE TEMOZOLOMIDE 140MG CAPSULE;ORAL Prescription No AB 206413 IDT AUSTRALIA LTD
TEMOZOLOMIDE TEMOZOLOMIDE 140MG CAPSULE;ORAL Prescription No AB 201742 SUN PHARM
TEMOZOLOMIDE TEMOZOLOMIDE 140MG CAPSULE;ORAL Prescription No AB 203959 WATSON LABS TEVA
TEMOZOLOMIDE TEMOZOLOMIDE 140MG CAPSULE;ORAL Prescription No AB 206750 ZYDUS PHARMS

CAPSULE;ORAL; 180MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TEMODAR TEMOZOLOMIDE 180MG CAPSULE;ORAL Prescription Yes AB 021029 MERCK SHARP DOHME
TEMOZOLOMIDE TEMOZOLOMIDE 180MG CAPSULE;ORAL Prescription No AB 201528 ACCORD HLTHCARE
TEMOZOLOMIDE TEMOZOLOMIDE 180MG CAPSULE;ORAL Prescription No AB 203490 AMERIGEN PHARMS LTD
TEMOZOLOMIDE TEMOZOLOMIDE 180MG CAPSULE;ORAL Prescription No AB 203691 AMNEAL PHARMS
TEMOZOLOMIDE TEMOZOLOMIDE 180MG CAPSULE;ORAL Prescription No AB 206309 ANDA REPOSITORY
TEMOZOLOMIDE TEMOZOLOMIDE 180MG CAPSULE;ORAL Prescription No AB 078879 BARR
TEMOZOLOMIDE TEMOZOLOMIDE 180MG CAPSULE;ORAL Prescription No AB 204639 CHEMI SPA
TEMOZOLOMIDE TEMOZOLOMIDE 180MG CAPSULE;ORAL Prescription No AB 207658 DEVA HOLDING AS
TEMOZOLOMIDE TEMOZOLOMIDE 180MG CAPSULE;ORAL Prescription No AB 206413 IDT AUSTRALIA LTD
TEMOZOLOMIDE TEMOZOLOMIDE 180MG CAPSULE;ORAL Prescription No AB 201742 SUN PHARM
TEMOZOLOMIDE TEMOZOLOMIDE 180MG CAPSULE;ORAL Prescription No AB 206750 ZYDUS PHARMS

CAPSULE;ORAL; 250MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
TEMODAR TEMOZOLOMIDE 250MG CAPSULE;ORAL Prescription Yes AB 021029 MERCK SHARP DOHME
TEMOZOLOMIDE TEMOZOLOMIDE 250MG CAPSULE;ORAL Prescription No AB 201528 ACCORD HLTHCARE
TEMOZOLOMIDE TEMOZOLOMIDE 250MG CAPSULE;ORAL Prescription No AB 203490 AMERIGEN PHARMS LTD
TEMOZOLOMIDE TEMOZOLOMIDE 250MG CAPSULE;ORAL Prescription No AB 203691 AMNEAL PHARMS
TEMOZOLOMIDE TEMOZOLOMIDE 250MG CAPSULE;ORAL Prescription No AB 206309 ANDA REPOSITORY
TEMOZOLOMIDE TEMOZOLOMIDE 250MG CAPSULE;ORAL Prescription No AB 078879 BARR
TEMOZOLOMIDE TEMOZOLOMIDE 250MG CAPSULE;ORAL Prescription No AB 204639 CHEMI SPA
TEMOZOLOMIDE TEMOZOLOMIDE 250MG CAPSULE;ORAL Prescription No AB 207658 DEVA HOLDING AS
TEMOZOLOMIDE TEMOZOLOMIDE 250MG CAPSULE;ORAL Prescription No AB 206413 IDT AUSTRALIA LTD
TEMOZOLOMIDE TEMOZOLOMIDE 250MG CAPSULE;ORAL Prescription No AB 201742 SUN PHARM
TEMOZOLOMIDE TEMOZOLOMIDE 250MG CAPSULE;ORAL Prescription No AB 203959 WATSON LABS TEVA
TEMOZOLOMIDE TEMOZOLOMIDE 250MG CAPSULE;ORAL Prescription No AB 206750 ZYDUS PHARMS

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English