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Drugs@FDA: FDA-Approved Drugs

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

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/203978Orig1s000ltr.pdf

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 0.9% 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

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
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
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