Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 020898
Company: GENZYME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THYROGEN THYROTROPIN ALFA 1.1MG/VIAL INJECTABLE;INJECTION Prescription None 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
11/30/1998 ORIG-1 Approval N/A; 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
03/12/2020 SUPPL-65 Supplement

Label is not available on this site.

03/12/2020 SUPPL-63 Supplement

Label is not available on this site.

04/24/2017 SUPPL-60 Supplement

Label is not available on this site.

06/12/2013 SUPPL-56 Supplement

Label is not available on this site.

05/07/2013 SUPPL-55 Supplement

Label is not available on this site.

03/21/2014 SUPPL-54 Supplement

Label is not available on this site.

12/14/2012 SUPPL-53 Supplement

Label is not available on this site.

07/27/2012 SUPPL-51 Supplement

Label is not available on this site.

08/12/2008 SUPPL-38 Supplement

Label is not available on this site.

01/24/2006 SUPPL-31 Supplement

Label is not available on this site.

12/14/2007 SUPPL-29 Supplement

Label is not available on this site.

03/11/2004 SUPPL-21 Supplement

Label is not available on this site.

10/08/2002 SUPPL-14 Supplement

Label is not available on this site.

06/25/2002 SUPPL-13 Supplement

Label is not available on this site.

09/17/2001 SUPPL-12 Supplement

Label is not available on this site.

06/13/2001 SUPPL-11 Supplement

Label is not available on this site.

03/15/2001 SUPPL-10 Supplement

Label is not available on this site.

03/01/2001 SUPPL-9 Supplement

Label is not available on this site.

03/01/2001 SUPPL-8 Supplement

Label is not available on this site.

02/28/2001 SUPPL-7 Supplement

Label is not available on this site.

10/26/2001 SUPPL-5 Supplement

Label is not available on this site.

05/25/2000 SUPPL-4 Supplement

Label is not available on this site.

11/16/1999 SUPPL-3 Supplement

Label is not available on this site.

09/02/1999 SUPPL-2 Supplement

Label is not available on this site.

09/03/1999 SUPPL-1 Supplement

Label is not available on this site.

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