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New Drug Application (NDA): 020763
Company: GLAXOSMITHKLINE LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMERGE NARATRIPTAN HYDROCHLORIDE EQ 2.5MG BASE TABLET;ORAL Prescription AB Yes Yes
AMERGE NARATRIPTAN HYDROCHLORIDE EQ 1MG BASE TABLET;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
02/10/1998 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20763lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20763ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20763_Amerge.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/29/2016 SUPPL-11 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020763s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020763Orig1s011ltr.pdf
10/16/2013 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020763s001s002s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020763Orig1s001,s002,s010ltr.pdf
03/02/2012 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020763s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020763s008,s009ltr.pdf
03/02/2012 SUPPL-8 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020763s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020763s008,s009ltr.pdf
08/11/2010 SUPPL-6 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020763s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020763s006ltr.pdf
10/27/2003 SUPPL-5 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20763slr005ltr.pdf
09/07/2001 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

07/21/2000 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

10/16/2013 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020763s001s002s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020763Orig1s001,s002,s010ltr.pdf
10/16/2013 SUPPL-1 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020763s001s002s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020763Orig1s001,s002,s010ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/29/2016 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020763s011lbl.pdf
10/16/2013 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020763s001s002s010lbl.pdf
10/16/2013 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020763s001s002s010lbl.pdf
10/16/2013 SUPPL-1 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020763s001s002s010lbl.pdf
03/02/2012 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020763s008s009lbl.pdf
03/02/2012 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020763s008s009lbl.pdf
08/11/2010 SUPPL-6 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020763s006lbl.pdf
02/10/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20763lbl.pdf

AMERGE

TABLET;ORAL; EQ 2.5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMERGE NARATRIPTAN HYDROCHLORIDE EQ 2.5MG BASE TABLET;ORAL Prescription Yes AB 020763 GLAXOSMITHKLINE LLC
NARATRIPTAN NARATRIPTAN HYDROCHLORIDE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 200502 HERITAGE PHARMS
NARATRIPTAN NARATRIPTAN HYDROCHLORIDE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 090381 HIKMA
NARATRIPTAN NARATRIPTAN HYDROCHLORIDE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 091441 ORBION PHARMS
NARATRIPTAN NARATRIPTAN HYDROCHLORIDE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 091326 PADAGIS US
NARATRIPTAN NARATRIPTAN HYDROCHLORIDE EQ 2.5MG BASE TABLET;ORAL Prescription No AB 091552 SUN PHARM INDS LTD

TABLET;ORAL; EQ 1MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMERGE NARATRIPTAN HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription Yes AB 020763 GLAXOSMITHKLINE LLC
NARATRIPTAN NARATRIPTAN HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 200502 HERITAGE PHARMS
NARATRIPTAN NARATRIPTAN HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 090381 HIKMA
NARATRIPTAN NARATRIPTAN HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 091441 ORBION PHARMS
NARATRIPTAN NARATRIPTAN HYDROCHLORIDE EQ 1MG BASE TABLET;ORAL Prescription No AB 091326 PADAGIS US
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