Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 215592
Company: CIPLA

Products on ANDA 215592

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	NICARDIPINE HYDROCHLORIDE	20MG/200ML (0.1MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	AP	No	No
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	NICARDIPINE HYDROCHLORIDE	40MG/200ML (0.2MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 215592

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/24/2024	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/28/2025	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 215592

NICARDIPINE HYDROCHLORIDE IN 0.9% 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
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	NICARDIPINE HYDROCHLORIDE	20MG/200ML (0.1MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	215592	CIPLA
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	NICARDIPINE HYDROCHLORIDE	20MG/200ML (0.1MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	Yes	AP	022276	HIKMA INTL PHARMS

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 0.9% SODIUM CHLORIDE	NICARDIPINE HYDROCHLORIDE	40MG/200ML (0.2MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	No	AP	215592	CIPLA
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	NICARDIPINE HYDROCHLORIDE	40MG/200ML (0.2MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	Yes	AP	022276	HIKMA INTL PHARMS