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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217548
Company: CHENGDU SHUODE

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
09/06/2024 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
12/18/2025 SUPPL-1 Labeling-Container/Carton Labels

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
CARDENE NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE;INJECTION Prescription Yes AP 019734 CHIESI
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 217548 CHENGDU SHUODE
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 090671 MANKIND PHARMA
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 216819 NANJING KING FRIEND
NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE;INJECTION Prescription No AP 219608 QILU PHARM HAINAN
NICARDIPINE HYDROCHLORIDE NICARDIPINE HYDROCHLORIDE 25MG/10ML (2.5MG/ML) INJECTABLE;INJECTION Prescription No AP 090664 SOMERSET THERAPS LLC
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