Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021016
Company: PFIZER IRELAND
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
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
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 205186 AJANTA PHARMA LTD
ELETRIPTAN HYDROBROMIDE ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 206787 AMNEAL PHARMS CO
ELETRIPTAN HYDROBROMIDE ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 210708 AUROBINDO PHARMA LTD
ELETRIPTAN HYDROBROMIDE ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET;ORAL Prescription No AB 205152 MYLAN PHARMS INC
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 USA INC
RELPAX ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET;ORAL Prescription Yes AB 021016 PFIZER IRELAND

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 205186 AJANTA PHARMA LTD
ELETRIPTAN HYDROBROMIDE ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 206787 AMNEAL PHARMS CO
ELETRIPTAN HYDROBROMIDE ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 210708 AUROBINDO PHARMA LTD
ELETRIPTAN HYDROBROMIDE ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET;ORAL Prescription No AB 205152 MYLAN PHARMS INC
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 USA INC
RELPAX ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET;ORAL Prescription Yes AB 021016 PFIZER IRELAND

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