Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 206787
Company: AMNEAL PHARMS CO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ELETRIPTAN HYDROBROMIDE ELETRIPTAN HYDROBROMIDE EQ 20MG BASE TABLET;ORAL Prescription AB No No
ELETRIPTAN HYDROBROMIDE ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET;ORAL Prescription AB No 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
05/25/2018 ORIG-1 Approval STANDARD

Label is not available on this site.

ELETRIPTAN HYDROBROMIDE

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
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
RELPAX ELETRIPTAN HYDROBROMIDE EQ 40MG BASE TABLET;ORAL Prescription Yes AB 021016 PFIZER IRELAND

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