Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201586
Company: LUPIN LTD

Products on ANDA 201586

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	EQ 5MG BASE;40MG	TABLET;ORAL	Prescription	AB	No	No
TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	EQ 10MG BASE;40MG	TABLET;ORAL	Prescription	AB	No	No
TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	EQ 5MG BASE;80MG	TABLET;ORAL	Prescription	AB	No	No
TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	EQ 10MG BASE;80MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 201586

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/08/2014	ORIG-1	Approval	Not Applicable		Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/201586Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/07/2019	SUPPL-6	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/02/2016	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
09/02/2016	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 201586

TELMISARTAN AND AMLODIPINE

TABLET;ORAL; EQ 5MG BASE;40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	EQ 5MG BASE;40MG	TABLET;ORAL	Prescription	No	AB	201586	LUPIN LTD
TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	EQ 5MG BASE;40MG	TABLET;ORAL	Prescription	No	AB	202516	MYLAN

TABLET;ORAL; EQ 10MG BASE;40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	EQ 10MG BASE;40MG	TABLET;ORAL	Prescription	No	AB	201586	LUPIN LTD
TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	EQ 10MG BASE;40MG	TABLET;ORAL	Prescription	No	AB	202516	MYLAN

TABLET;ORAL; EQ 5MG BASE;80MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	EQ 5MG BASE;80MG	TABLET;ORAL	Prescription	No	AB	201586	LUPIN LTD
TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	EQ 5MG BASE;80MG	TABLET;ORAL	Prescription	No	AB	202516	MYLAN

TABLET;ORAL; EQ 10MG BASE;80MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	EQ 10MG BASE;80MG	TABLET;ORAL	Prescription	No	AB	201586	LUPIN LTD
TELMISARTAN AND AMLODIPINE	AMLODIPINE BESYLATE; TELMISARTAN	EQ 10MG BASE;80MG	TABLET;ORAL	Prescription	No	AB	202516	MYLAN