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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206409
Company: ZYDUS PHARMS

Products on ANDA 206409

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206409

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/16/2017	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206409Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/24/2020	SUPPL-3	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 206409

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	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	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	205186	AJANTA PHARMA LTD
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	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

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