اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
AMERGE از شرکت GLAXOSMITHKLINE LLC
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 |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20763lbl.pdf |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 INC |
| 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 | ORCHID HLTHCARE |
| 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 INC |
| 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 | ORCHID HLTHCARE |
| NARATRIPTAN | NARATRIPTAN HYDROCHLORIDE | EQ 1MG BASE | TABLET;ORAL | Prescription | No | AB | 091326 | PADAGIS US |
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