An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 204800
Company: YUNG SHIN PHARM

Products on ANDA 204800

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 204800

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/29/2019	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
12/23/2024	SUPPL-3	Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 204800

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
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	200815	PH HEALTH
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	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
FELODIPINE	FELODIPINE	5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203032	ORBION PHARMS
FELODIPINE	FELODIPINE	5MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	200815	PH HEALTH
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	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
FELODIPINE	FELODIPINE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	203032	ORBION PHARMS
FELODIPINE	FELODIPINE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	200815	PH HEALTH
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	210847	YILING
FELODIPINE	FELODIPINE	10MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	204800	YUNG SHIN PHARM

Top