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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021016
Company: UPJOHN

Other Important Information from FDA

Products on NDA 021016

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021016

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.html

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

Labels for NDA 021016

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

Therapeutic Equivalents for NDA 021016

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	219143	ANNORA PHARMA
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	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	215467	REGCON HOLDINGS
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	219143	ANNORA PHARMA
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	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	215467	REGCON HOLDINGS
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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