Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021016
Company: UPJOHN
Company: UPJOHN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
RELPAX | ELETRIPTAN HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | AB | Yes | No |
RELPAX | ELETRIPTAN HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/26/2002 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21016_relpax_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21016ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21016_Relpax.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
03/24/2020 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/21016s029lbl.pdf | |
09/18/2015 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/03/2013 | SUPPL-27 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021016s021s023s024s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021016Orig1s021,s023,s024,s027ltr.pdf | |
12/03/2013 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/07/2013 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/03/2013 | SUPPL-24 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021016s021s023s024s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021016Orig1s021,s023,s024,s027ltr.pdf | |
10/03/2013 | SUPPL-23 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021016s021s023s024s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021016Orig1s021,s023,s024,s027ltr.pdf | |
10/03/2013 | SUPPL-21 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021016s021s023s024s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021016Orig1s021,s023,s024,s027ltr.pdf | |
04/13/2011 | SUPPL-18 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021016s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021016s018ltr.pdf | |
07/21/2010 | SUPPL-16 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021016s009s016.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021016s009,s016ltr.pdf | |
07/21/2010 | SUPPL-9 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021016s009s016.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021016s009,s016ltr.pdf | |
07/27/2005 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
05/06/2004 | SUPPL-3 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21016slr003ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/24/2020 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/21016s029lbl.pdf | |
10/03/2013 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021016s021s023s024s027lbl.pdf | |
10/03/2013 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021016s021s023s024s027lbl.pdf | |
10/03/2013 | SUPPL-23 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021016s021s023s024s027lbl.pdf | |
10/03/2013 | SUPPL-21 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021016s021s023s024s027lbl.pdf | |
04/13/2011 | SUPPL-18 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021016s018lbl.pdf | |
07/21/2010 | SUPPL-16 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021016s009s016.pdf | |
07/21/2010 | SUPPL-9 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021016s009s016.pdf | |
12/26/2002 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21016_relpax_lbl.pdf |
RELPAX
TABLET;ORAL; EQ 20MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ELETRIPTAN HYDROBROMIDE | ELETRIPTAN HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 210708 | AUROBINDO PHARMA |
ELETRIPTAN HYDROBROMIDE | ELETRIPTAN HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 215467 | BEXIMCO PHARMS USA |
ELETRIPTAN HYDROBROMIDE | ELETRIPTAN HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 205186 | CHARTWELL RX |
ELETRIPTAN HYDROBROMIDE | ELETRIPTAN HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 205152 | MYLAN |
ELETRIPTAN HYDROBROMIDE | ELETRIPTAN HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 202040 | TEVA PHARMS USA |
ELETRIPTAN HYDROBROMIDE | ELETRIPTAN HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 206409 | ZYDUS PHARMS |
RELPAX | ELETRIPTAN HYDROBROMIDE | EQ 20MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021016 | UPJOHN |
TABLET;ORAL; EQ 40MG BASE
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ELETRIPTAN HYDROBROMIDE | ELETRIPTAN HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 210708 | AUROBINDO PHARMA |
ELETRIPTAN HYDROBROMIDE | ELETRIPTAN HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 215467 | BEXIMCO PHARMS USA |
ELETRIPTAN HYDROBROMIDE | ELETRIPTAN HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 205186 | CHARTWELL RX |
ELETRIPTAN HYDROBROMIDE | ELETRIPTAN HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 205152 | MYLAN |
ELETRIPTAN HYDROBROMIDE | ELETRIPTAN HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 202040 | TEVA PHARMS USA |
ELETRIPTAN HYDROBROMIDE | ELETRIPTAN HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | No | AB | 206409 | ZYDUS PHARMS |
RELPAX | ELETRIPTAN HYDROBROMIDE | EQ 40MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021016 | UPJOHN |