Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020057
Company: GENZYME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEREDASE ALGLUCERASE 80 UNITS/ML INJECTABLE;INJECTION Discontinued None No No
CEREDASE ALGLUCERASE 10 UNITS/ML INJECTABLE;INJECTION Discontinued 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
04/05/1991 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
01/30/2002 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

09/24/2001 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

04/30/1999 SUPPL-35 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

02/09/2006 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020057s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020057s034ltr.pdf
11/27/1996 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

07/23/1996 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

09/11/1996 SUPPL-31 Labeling

Label is not available on this site.

07/03/1996 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

05/21/1996 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

03/26/1996 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

12/21/1995 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

11/09/1995 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

10/16/1995 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

06/08/1995 SUPPL-23 Labeling

Label is not available on this site.

06/19/1995 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

12/14/1994 SUPPL-21 Labeling

Label is not available on this site.

10/26/1995 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

12/06/1994 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

08/03/1994 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

01/07/1994 SUPPL-17 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/17/1994 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/1996 SUPPL-14 Labeling

Label is not available on this site.

10/01/1993 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

01/07/1994 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/17/1994 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

06/16/1993 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

05/28/1993 SUPPL-9 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

06/30/1993 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/09/1993 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

06/19/1995 SUPPL-6 Labeling

Label is not available on this site.

06/30/1993 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/08/1992 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/24/1991 SUPPL-2 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

11/27/1991 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/09/2006 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020057s034lbl.pdf

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