Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202313
Company: EMCURE PHARMS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADENOSINE ADENOSINE 60MG/20ML (3MG/ML) SOLUTION;IV (INFUSION) Prescription AP No No
ADENOSINE ADENOSINE 90MG/30ML (3MG/ML) SOLUTION;IV (INFUSION) 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
09/15/2014 ORIG-1 Approval

Label is not available on this site.

ADENOSINE

SOLUTION;IV (INFUSION); 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;IV (INFUSION) Prescription No AP 090450 AKORN
ADENOSINE ADENOSINE 60MG/20ML (3MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 205331 AUROBINDO PHARMA LTD
ADENOSINE ADENOSINE 60MG/20ML (3MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 202313 EMCURE PHARMS LTD
ADENOSINE ADENOSINE 60MG/20ML (3MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 203883 HOSPIRA INC
ADENOSINE ADENOSINE 60MG/20ML (3MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 090212 SAGENT STRIDES
ADENOSINE ADENOSINE 60MG/20ML (3MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 077425 TEVA PHARMS USA

SOLUTION;IV (INFUSION); 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;IV (INFUSION) Prescription No AP 090450 AKORN
ADENOSINE ADENOSINE 90MG/30ML (3MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 205331 AUROBINDO PHARMA LTD
ADENOSINE ADENOSINE 90MG/30ML (3MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 202313 EMCURE PHARMS LTD
ADENOSINE ADENOSINE 90MG/30ML (3MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 203883 HOSPIRA INC
ADENOSINE ADENOSINE 90MG/30ML (3MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 090212 SAGENT STRIDES
ADENOSINE ADENOSINE 90MG/30ML (3MG/ML) SOLUTION;IV (INFUSION) Prescription No AP 077425 TEVA PHARMS USA

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