Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 203978
Company: INFORLIFE

Products on ANDA 203978

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE	NICARDIPINE HYDROCHLORIDE	40MG/200ML (0.2MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	AP	No	No
NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE	NICARDIPINE HYDROCHLORIDE	20MG/200ML (0.1MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 203978

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/17/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 203978

NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE

INJECTABLE;INTRAVENOUS; 40MG/200ML (0.2MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER	NICARDIPINE HYDROCHLORIDE	40MG/200ML (0.2MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	Yes	AP	019734	CHIESI
NICARDIPINE HYDROCHLORIDE IN 0.83% SODIUM CHLORIDE	NICARDIPINE HYDROCHLORIDE	40MG/200ML (0.2MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	203978	INFORLIFE

NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE

INJECTABLE;INTRAVENOUS; 20MG/200ML (0.1MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER	NICARDIPINE HYDROCHLORIDE	20MG/200ML (0.1MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	Yes	AP	019734	CHIESI
NICARDIPINE HYDROCHLORIDE IN 0.86% SODIUM CHLORIDE	NICARDIPINE HYDROCHLORIDE	20MG/200ML (0.1MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	203978	INFORLIFE