Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020763
Company: GLAXOSMITHKLINE LLC
Company: GLAXOSMITHKLINE LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
AMERGE | NARATRIPTAN HYDROCHLORIDE | EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
AMERGE | NARATRIPTAN HYDROCHLORIDE | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |