Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021029
Company: MERCK SHARP DOHME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TEMODAR TEMOZOLOMIDE 5MG CAPSULE;ORAL Prescription AB Yes No
TEMODAR TEMOZOLOMIDE 20MG CAPSULE;ORAL Prescription AB Yes No
TEMODAR TEMOZOLOMIDE 100MG CAPSULE;ORAL Prescription AB Yes No
TEMODAR TEMOZOLOMIDE 250MG CAPSULE;ORAL Prescription AB Yes Yes
TEMODAR TEMOZOLOMIDE 140MG CAPSULE;ORAL Prescription AB Yes No
TEMODAR TEMOZOLOMIDE 180MG CAPSULE;ORAL Prescription AB Yes 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
08/11/1999 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21029ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21029_Temodar.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/06/2017 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021029s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021029Orig1s032ltr.pdf
02/12/2016 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021029s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021029Orig1s031ltr.pdf
02/24/2017 SUPPL-30 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021029Orig1s030ltr.pdf
09/18/2015 SUPPL-29 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021029Orig1s029ltr.pdf
04/02/2015 SUPPL-28 Labeling-Package Insert, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021029Orig1s028ltr.pdf
09/19/2014 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

05/05/2014 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021029s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021029Orig1s026ltr.pdf
10/10/2013 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/20/2014 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

01/08/2013 SUPPL-22 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021029s022lbl.pdf
06/03/2011 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021029s021,022277s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022277s005,021029s021ltr.pdf
02/04/2011 SUPPL-20 Labeling-Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021029s020,022277s004lbl.pdf
04/26/2010 SUPPL-18 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021029s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021029s018,022277s001ltr.pdf
10/19/2006 SUPPL-12 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021029s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021029s012ltr.pdf
03/31/2006 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021029s008, s011ltr.pdf
04/22/2005 SUPPL-10 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021029s010ltr.pdf
03/30/2005 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21029s009ltr.pdf
03/15/2005 SUPPL-8 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021029s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21029s008ltr.pdf
06/29/2004 SUPPL-7 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21029slr007ltr.pdf
07/15/2004 SUPPL-6 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21029s006ltr.pdf
03/11/2003 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21029se8-005_temodar_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21029se8-005ltr.pdf
01/18/2002 SUPPL-4 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/021029-S004_TEMODAR_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21029s4ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21029-S004_TEMODAR_review.pdf
03/05/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

05/18/2001 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

06/09/2000 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/06/2017 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021029s032lbl.pdf
02/24/2017 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021029s030lbl.pdf
02/12/2016 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021029s031lbl.pdf
09/18/2015 SUPPL-29 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s029lbl.pdf
04/02/2015 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s028lbl.pdf
04/02/2015 SUPPL-28 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021029s028lbl.pdf
05/05/2014 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021029s026lbl.pdf
01/08/2013 SUPPL-22 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021029s022lbl.pdf
06/03/2011 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021029s021,022277s005lbl.pdf
02/04/2011 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021029s020,022277s004lbl.pdf
04/26/2010 SUPPL-18 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021029s018lbl.pdf
10/19/2006 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021029s012lbl.pdf
10/19/2006 SUPPL-12 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021029s012lbl.pdf
03/15/2005 SUPPL-8 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021029s008lbl.pdf
03/11/2003 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21029se8-005_temodar_lbl.pdf
01/18/2002 SUPPL-4 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/021029-S004_TEMODAR_lbl.pdf
08/11/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21029lbl.pdf

TEMODAR

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 203898 LANNETT CO INC
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 203898 LANNETT CO INC
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 203898 LANNETT CO INC
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 203898 LANNETT CO INC
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 203898 LANNETT CO INC
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 203898 LANNETT CO INC
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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