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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 216420
Company: MICRO LABS

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

Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
07/07/2023 ORIG-1 Approval STANDARD

Label is not available on this site.

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
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