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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216357
Company: GLENMARK PHARMS LTD

Products on ANDA 216357

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE;ORAL	Prescription	AB	No	No
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 216357

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/16/2022	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 216357

NICARDIPINE HYDROCHLORIDE

CAPSULE;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE;ORAL	Prescription	No	AB	218202	AMNEAL
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE;ORAL	Prescription	No	AB	074670	ANI PHARMS
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE;ORAL	Prescription	No	AB	217555	BIONPHARMA
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE;ORAL	Prescription	No	AB	074928	EPIC PHARMA LLC
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE;ORAL	Prescription	No	AB	216357	GLENMARK PHARMS LTD
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	20MG	CAPSULE;ORAL	Prescription	No	AB	215377	SENORES PHARMS

CAPSULE;ORAL; 30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	No	AB	218202	AMNEAL
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	No	AB	074670	ANI PHARMS
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	No	AB	217555	BIONPHARMA
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	No	AB	074928	EPIC PHARMA LLC
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	No	AB	216357	GLENMARK PHARMS LTD
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	30MG	CAPSULE;ORAL	Prescription	No	AB	215377	SENORES PHARMS

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