Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078076
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADENOSINE ADENOSINE 3MG/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
10/31/2008 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
05/20/2015 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

09/30/2013 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

ADENOSINE

INJECTABLE;INJECTION; 3MG/ML
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADENOCARD ADENOSINE 3MG/ML INJECTABLE;INJECTION Prescription Yes AP 019937 ASTELLAS
ADENOSINE ADENOSINE 3MG/ML INJECTABLE;INJECTION Prescription No AP 078076 AKORN
ADENOSINE ADENOSINE 3MG/ML INJECTABLE;INJECTION Prescription No AP 077133 FRESENIUS KABI USA
ADENOSINE ADENOSINE 3MG/ML INJECTABLE;INJECTION Prescription No AP 077283 GLAND PHARMA LTD
ADENOSINE ADENOSINE 3MG/ML INJECTABLE;INJECTION Prescription No AP 090010 LUITPOLD
ADENOSINE ADENOSINE 3MG/ML INJECTABLE;INJECTION Prescription No AP 078640 MYLAN LABS LTD
ADENOSINE ADENOSINE 3MG/ML INJECTABLE;INJECTION Prescription No AP 078686 MYLAN LABS LTD
ADENOSINE ADENOSINE 3MG/ML INJECTABLE;INJECTION Prescription No AP 076404 WEST-WARD PHARMS INT
ADENOSINE ADENOSINE 3MG/ML INJECTABLE;INJECTION Prescription No AP 076500 WEST-WARD PHARMS INT

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