Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078879
Company: BARR
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 250MG CAPSULE;ORAL Prescription AB No No
TEMOZOLOMIDE TEMOZOLOMIDE 140MG CAPSULE;ORAL Prescription AB No No
TEMOZOLOMIDE TEMOZOLOMIDE 180MG 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
03/01/2010 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2010/078879Orig1s000.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/23/2015 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

11/23/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

11/23/2015 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

04/30/2013 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

09/13/2011 SUPPL-4 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

07/28/2010 SUPPL-1 Labeling-Package Insert

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; 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

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

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