Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077283
Company: GLAND PHARMA LTD

Products on ANDA 077283

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 077283

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/14/2007	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
11/20/2009	SUPPL-6	Labeling		Label is not available on this site.
04/14/2008	SUPPL-4	Labeling		Label is not available on this site.
01/14/2008	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 077283

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