Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019818
Company: SIGMA TAU
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADAGEN PEGADEMASE BOVINE 250 UNITS/ML INJECTABLE;INJECTION Prescription None 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
03/21/1990 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/21/2015 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

07/17/2014 SUPPL-55 Manufacturing (CMC)

Label is not available on this site.

06/05/2014 SUPPL-53 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019818s053lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019818Orig1s053ltr.pdf
03/04/2014 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

12/17/2013 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

01/10/2014 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

10/15/2013 SUPPL-48 Manufacturing (CMC)

Label is not available on this site.

10/07/2013 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

01/15/2013 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

09/25/2008 SUPPL-42 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019818s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019818s042ltr.pdf
10/26/2007 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019818s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019818s034ltr.pdf
04/15/2002 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/17/2001 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

09/16/1998 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

12/06/1993 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

06/16/1994 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

08/11/1993 SUPPL-11 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/10/1992 SUPPL-9 Labeling

Label is not available on this site.

12/28/1992 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

03/09/1993 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

04/22/1992 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

04/13/1992 SUPPL-4 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/27/1991 SUPPL-3 Labeling

Label is not available on this site.

06/10/1991 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

11/28/1990 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
06/05/2014 SUPPL-53 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019818s053lbl.pdf
09/25/2008 SUPPL-42 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019818s042lbl.pdf
10/26/2007 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019818s034lbl.pdf

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