Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076500
Company: HIKMA

Products on ANDA 076500

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ADENOSINE	ADENOSINE	3MG/ML	INJECTABLE;INJECTION	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076500

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/16/2004	ORIG-1	Approval			Letter (PDF) Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76500ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/076500.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/06/2010	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
11/21/2006	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076500

ADENOSINE

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

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ADENOSINE	ADENOSINE	3MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	077133	FRESENIUS KABI USA
ADENOSINE	ADENOSINE	3MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	205568	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	206778	GLAND PHARMA LTD
ADENOSINE	ADENOSINE	3MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	076404	HIKMA
ADENOSINE	ADENOSINE	3MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	076500	HIKMA
ADENOSINE	ADENOSINE	3MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	078686	MYLAN LABS LTD
ADENOSINE	ADENOSINE	3MG/ML	INJECTABLE;INJECTION	Prescription	No	AP	078076	RISING