Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 079134
Company: MYLAN ASI
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
02/03/2010 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/22/2015 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

03/17/2015 SUPPL-6 Labeling-Container/Carton Labels

Label is not available on this site.

08/24/2012 SUPPL-4 Labeling-Package Insert

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 INC
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 075239 HOSPIRA
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE;INJECTION Prescription No AP 075240 HOSPIRA
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE;INJECTION Prescription No AP 079134 MYLAN ASI
LABETALOL HYDROCHLORIDE LABETALOL HYDROCHLORIDE 5MG/ML INJECTABLE;INJECTION Prescription No AP 075303 WEST-WARD PHARMS INT

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