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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022276
Company: HIKMA INTL PHARMS

Safety Labeling Change Order Letter

Summary Review

Products on NDA 022276

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	Yes	Yes
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	NICARDIPINE HYDROCHLORIDE	20MG/200ML (0.1MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	None	Yes	Yes
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE	NICARDIPINE HYDROCHLORIDE	40MG/200ML (0.2MG/ML)	INJECTABLE;INTRAVENOUS	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022276

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/24/2008	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022276lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022276s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022276s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022276s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/07/2022	SUPPL-20	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022276Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022276Orig1s020ltr.pdf
06/01/2021	SUPPL-18	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022276Orig1s018ltr.pdf
09/23/2016	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022276s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022276Orig1s011ltr.pdf
10/28/2014	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
04/07/2016	SUPPL-8	Manufacturing (CMC)	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022276s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022276Orig1s008ltr_.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/022276Orig1s008.pdf
01/10/2013	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
01/08/2009	SUPPL-3	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022276s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022276s003ltr.pdf

Labels for NDA 022276

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/07/2022	SUPPL-20	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022276Orig1s020lbl.pdf
01/07/2022	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022276Orig1s020lbl.pdf
09/23/2016	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022276s011lbl.pdf
04/07/2016	SUPPL-8	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022276s008lbl.pdf
01/08/2009	SUPPL-3	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022276s003lbl.pdf
07/24/2008	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022276lbl.pdf

Therapeutic Equivalents for NDA 022276

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

NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE

There are no Therapeutic Equivalents.

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