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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076500
Company: HIKMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADENOSINE ADENOSINE 3MG/ML INJECTABLE;INJECTION 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
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.

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
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