Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202516
Company: MYLAN

Products on ANDA 202516

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	Yes

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202516

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/26/2014	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/09/2019	SUPPL-6	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
09/09/2019	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
11/17/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
01/02/2015	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202516

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