Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077161
Company: GLAND PHARMA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription AP No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
04/20/2005 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
05/21/2013 SUPPL-7 Labeling-Container/Carton Labels

Label is not available on this site.

07/30/2010 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

11/20/2009 SUPPL-5 Labeling

Label is not available on this site.

01/15/2009 SUPPL-4 Labeling

Label is not available on this site.

08/22/2008 SUPPL-3 Labeling

Label is not available on this site.

AMIODARONE HYDROCHLORIDE

INJECTABLE;INJECTION; 50MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 076232 AKORN
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 204550 AUROBINDO PHARMA LTD
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 075761 FRESENIUS KABI USA
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 077161 GLAND PHARMA LTD
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 077234 HIKMA FARMACEUTICA
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 075955 HOSPIRA
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 203884 HOSPIRA INC
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 203885 HOSPIRA INC
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 076217 MYLAN INSTITUTIONAL
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 077610 WOCKHARDT
AMIODARONE HYDROCHLORIDE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription No AP 077834 WOCKHARDT
NEXTERONE AMIODARONE HYDROCHLORIDE 50MG/ML INJECTABLE;INJECTION Prescription Yes AP 022325 BAXTER HLTHCARE

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