Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090664
Company: RK PHARMA

Products on ANDA 090664

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 090664

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/17/2009	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
05/27/2020	SUPPL-5	Labeling-Package Insert		Label is not available on this site.
05/27/2020	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
12/31/2011	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 090664

NICARDIPINE HYDROCHLORIDE

INJECTABLE;INJECTION; 25MG/10ML (2.5MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	090534	AM REGENT
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	211121	EUGIA PHARMA
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE;INJECTION	Prescription	Yes	AP	022276	HIKMA INTL PHARMS
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	216420	MICRO LABS
NICARDIPINE HYDROCHLORIDE	NICARDIPINE HYDROCHLORIDE	25MG/10ML (2.5MG/ML)	INJECTABLE;INJECTION	Prescription	No	AP	090664	RK PHARMA