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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077425
Company: MEITHEAL

Products on ANDA 077425

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 077425

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-Patient Package Insert, Labeling-Container/Carton Labels, 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.

Labels for ANDA 077425

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

Therapeutic Equivalents for ANDA 077425

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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