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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214533
Company: CAPLIN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 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
09/07/2021 ORIG-1 Approval STANDARD

Label is not available on this site.

LABETALOL HYDROCHLORIDE

INJECTABLE;INJECTION; 5MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE;INJECTION Prescription No AP 075431 AKORN
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE;INJECTION Prescription No AP 076051 BAXTER HLTHCARE CORP
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE;INJECTION Prescription No AP 214533 CAPLIN
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE;INJECTION Prescription No AP 090699 GLAND PHARMA LTD
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE;INJECTION Prescription No AP 075303 HIKMA
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE;INJECTION Prescription No AP 075239 HOSPIRA
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE;INJECTION Prescription No AP 075240 HOSPIRA
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