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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208538
Company: GLAND PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE 10MG/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
08/14/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

ESMOLOL HYDROCHLORIDE

INJECTABLE;INJECTION; 10MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BREVIBLOC ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Prescription Yes AP 019386 BAXTER HLTHCARE
ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Prescription No AP 205520 EUGIA PHARMA
ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Prescription No AP 216244 EUGIA PHARMA
ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Prescription No AP 076573 FRESENIUS KABI USA
ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Prescription No AP 208538 GLAND PHARMA LTD
ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Prescription No AP 076323 HIKMA
ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Prescription No AP 076474 MYLAN INSTITUTIONAL
ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Prescription No AP 206608 MYLAN LABS LTD
ESMOLOL HYDROCHLORIDE ESMOLOL HYDROCHLORIDE 10MG/ML INJECTABLE;INJECTION Prescription No AP 207107 SAGENT PHARMS INC
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