Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019937
Company: ASTELLAS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADENOCARD ADENOSINE 3MG/ML INJECTABLE;INJECTION Prescription AP Yes 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
10/30/1989 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/13/2013 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

02/23/2011 SUPPL-26 Labeling-Package Insert

Label is not available on this site.

11/06/2009 SUPPL-24 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019937s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019937s024ltr.pdf
07/14/2005 SUPPL-21 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019937s021,020059s011ltr.pdf
09/21/2001 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/01/2000 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

11/02/1999 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

04/20/1999 SUPPL-15 Labeling

Label is not available on this site.

02/13/1997 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

07/29/1996 SUPPL-13 Labeling

Label is not available on this site.

12/27/1995 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

02/09/1996 SUPPL-11 Labeling

Label is not available on this site.

06/26/1995 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

06/09/1995 SUPPL-9 Labeling

Label is not available on this site.

10/27/1993 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

06/11/1992 SUPPL-7 Labeling

Label is not available on this site.

11/15/1990 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

09/13/1990 SUPPL-4 Labeling

Label is not available on this site.

04/25/1994 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/10/1990 SUPPL-2 Labeling

Label is not available on this site.

12/04/1989 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
11/06/2009 SUPPL-24 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019937s024lbl.pdf

ADENOCARD

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

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ADENOCARD ADENOSINE 3MG/ML INJECTABLE;INJECTION Prescription Yes AP 019937 ASTELLAS
ADENOSINE ADENOSINE 3MG/ML INJECTABLE;INJECTION Prescription No AP 078076 AKORN
ADENOSINE ADENOSINE 3MG/ML INJECTABLE;INJECTION Prescription No AP 077133 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 090010 LUITPOLD
ADENOSINE ADENOSINE 3MG/ML INJECTABLE;INJECTION Prescription No AP 078640 MYLAN LABS LTD
ADENOSINE ADENOSINE 3MG/ML INJECTABLE;INJECTION Prescription No AP 078686 MYLAN LABS LTD
ADENOSINE ADENOSINE 3MG/ML INJECTABLE;INJECTION Prescription No AP 076404 WEST-WARD PHARMS INT
ADENOSINE ADENOSINE 3MG/ML INJECTABLE;INJECTION Prescription No AP 076500 WEST-WARD PHARMS INT

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