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Abbreviated New Drug Application (ANDA): 077425
Company: MEITHEAL
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 Yes
ADENOSINE ADENOSINE 90MG/30ML (3MG/ML) SOLUTION;INTRAVENOUS 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
08/29/2013 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/077425Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/077425Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/27/2023 SUPPL-9 Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

05/18/2015 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

05/18/2015 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/29/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/077425Orig1s000lbl.pdf

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 202313 AVET LIFESCIENCES
ADENOSINE ADENOSINE 60MG/20ML (3MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 205331 EUGIA PHARMA
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 077425 MEITHEAL
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 090450 RISING

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 202313 AVET LIFESCIENCES
ADENOSINE ADENOSINE 90MG/30ML (3MG/ML) SOLUTION;INTRAVENOUS Prescription No AP 205331 EUGIA PHARMA
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 077425 MEITHEAL
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 090450 RISING
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