Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 203883
Company: HOSPIRA INC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADENOSINE ADENOSINE 60MG/20ML (3MG/ML) SOLUTION;INTRAVENOUS Prescription AP No No
ADENOSINE ADENOSINE 90MG/30ML (3MG/ML) SOLUTION;INTRAVENOUS 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
03/24/2014 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
09/17/2015 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

ADENOSINE

SOLUTION;INTRAVENOUS; 60MG/20ML (3MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADENOSINE ADENOSINE 60MG/20ML (3MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 090450 AKORN
ADENOSINE ADENOSINE 60MG/20ML (3MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 205331 AUROBINDO PHARMA LTD
ADENOSINE ADENOSINE 60MG/20ML (3MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 202313 EMCURE PHARMS LTD
ADENOSINE ADENOSINE 60MG/20ML (3MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 077897 FRESENIUS KABI USA
ADENOSINE ADENOSINE 60MG/20ML (3MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 203883 HOSPIRA INC
ADENOSINE ADENOSINE 60MG/20ML (3MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 090212 MYLAN ASI
ADENOSINE ADENOSINE 60MG/20ML (3MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 077425 TEVA PHARMS USA

SOLUTION;INTRAVENOUS; 90MG/30ML (3MG/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADENOSINE ADENOSINE 90MG/30ML (3MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 090450 AKORN
ADENOSINE ADENOSINE 90MG/30ML (3MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 205331 AUROBINDO PHARMA LTD
ADENOSINE ADENOSINE 90MG/30ML (3MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 202313 EMCURE PHARMS LTD
ADENOSINE ADENOSINE 90MG/30ML (3MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 077897 FRESENIUS KABI USA
ADENOSINE ADENOSINE 90MG/30ML (3MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 203883 HOSPIRA INC
ADENOSINE ADENOSINE 90MG/30ML (3MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 090212 MYLAN ASI
ADENOSINE ADENOSINE 90MG/30ML (3MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 077425 TEVA PHARMS USA

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