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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090365
Company: GLENMARK PHARMS LTD

Products on ANDA 090365

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FELODIPINE	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
FELODIPINE	FELODIPINE	5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
FELODIPINE	FELODIPINE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090365

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/17/2010	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
11/30/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090365

FELODIPINE

TABLET, EXTENDED RELEASE;ORAL; 2.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FELODIPINE	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203417	AUROBINDO PHARMA LTD
FELODIPINE	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	090365	GLENMARK PHARMS LTD
FELODIPINE	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	201964	HERITAGE PHARMS
FELODIPINE	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203032	ORBION PHARMS
FELODIPINE	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	091200	SUN PHARM INDS LTD
FELODIPINE	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	202170	TORRENT PHARMS LTD
FELODIPINE	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	200815	VINTAGE PHARMS LLC
FELODIPINE	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	210847	YILING
FELODIPINE	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204800	YUNG SHIN PHARM

TABLET, EXTENDED RELEASE;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FELODIPINE	FELODIPINE	5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203417	AUROBINDO PHARMA LTD
FELODIPINE	FELODIPINE	5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	090365	GLENMARK PHARMS LTD
FELODIPINE	FELODIPINE	5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	201964	HERITAGE PHARMS
FELODIPINE	FELODIPINE	5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203032	ORBION PHARMS
FELODIPINE	FELODIPINE	5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	091200	SUN PHARM INDS LTD
FELODIPINE	FELODIPINE	5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	202170	TORRENT PHARMS LTD
FELODIPINE	FELODIPINE	5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	200815	VINTAGE PHARMS LLC
FELODIPINE	FELODIPINE	5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	210847	YILING
FELODIPINE	FELODIPINE	5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204800	YUNG SHIN PHARM

TABLET, EXTENDED RELEASE;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FELODIPINE	FELODIPINE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203417	AUROBINDO PHARMA LTD
FELODIPINE	FELODIPINE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	090365	GLENMARK PHARMS LTD
FELODIPINE	FELODIPINE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	201964	HERITAGE PHARMS
FELODIPINE	FELODIPINE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203032	ORBION PHARMS
FELODIPINE	FELODIPINE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	091200	SUN PHARM INDS LTD
FELODIPINE	FELODIPINE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	202170	TORRENT PHARMS LTD
FELODIPINE	FELODIPINE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	200815	VINTAGE PHARMS LLC
FELODIPINE	FELODIPINE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	210847	YILING
FELODIPINE	FELODIPINE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204800	YUNG SHIN PHARM

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