Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020367
Company: GENZYME
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEREZYME IMIGLUCERASE 200 UNITS/VIAL INJECTABLE;INJECTION Prescription None Yes No
CEREZYME IMIGLUCERASE 400 UNITS/VIAL 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
05/23/1994 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
07/22/2016 SUPPL-101 Manufacturing (CMC)

Label is not available on this site.

07/07/2016 SUPPL-99 Manufacturing (CMC)

Label is not available on this site.

06/08/2016 SUPPL-98 Manufacturing (CMC)

Label is not available on this site.

04/21/2016 SUPPL-97 Manufacturing (CMC)

Label is not available on this site.

03/03/2016 SUPPL-96 Manufacturing (CMC)

Label is not available on this site.

10/30/2015 SUPPL-95 Manufacturing (CMC)

Label is not available on this site.

08/10/2015 SUPPL-94 Manufacturing (CMC)

Label is not available on this site.

03/09/2015 SUPPL-92 Manufacturing (CMC)

Label is not available on this site.

09/05/2014 SUPPL-91 Manufacturing (CMC)

Label is not available on this site.

02/27/2014 SUPPL-90 Manufacturing (CMC)

Label is not available on this site.

10/30/2013 SUPPL-89 Manufacturing (CMC)

Label is not available on this site.

07/31/2013 SUPPL-88 Manufacturing (CMC)

Label is not available on this site.

03/03/2005 SUPPL-66 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20367s066lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20367s066ltr.pdf
10/09/2002 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

11/13/2002 SUPPL-55 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20367slr055_Cerezyme_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20367slr055ltr.pdf
06/14/2002 SUPPL-53 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20367s53lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20367s053ltr.pdf
05/08/2001 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

05/07/2001 SUPPL-50 Manufacturing (CMC)-Control

Label is not available on this site.

08/13/2001 SUPPL-49 Labeling

Label is not available on this site.

11/14/2000 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

10/27/2000 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

08/31/2000 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

09/11/2000 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

07/10/2000 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

04/10/2000 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

08/13/2001 SUPPL-42 Labeling

Label is not available on this site.

08/13/2001 SUPPL-41 Labeling

Label is not available on this site.

12/08/1999 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

09/07/1999 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

10/22/1999 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

10/05/1999 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

07/28/1999 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

07/26/1999 SUPPL-35 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/22/1999 SUPPL-34 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/04/1999 SUPPL-33 Manufacturing (CMC)-Control

Label is not available on this site.

11/18/1998 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

06/17/1998 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

06/12/1998 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

06/12/1998 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

03/23/1998 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

02/11/1999 SUPPL-27 Labeling

Label is not available on this site.

01/30/1998 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/1997 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

07/31/1997 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

07/16/1997 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

12/20/1996 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

03/03/1997 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

09/23/1996 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

12/12/1996 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

10/22/1996 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

09/20/1996 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/05/1996 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

04/08/1996 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

02/23/1996 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

05/31/1996 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

12/06/1995 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

04/18/1996 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/24/1995 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1997 SUPPL-6 Labeling

Label is not available on this site.

05/03/1995 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/08/1995 SUPPL-4 Manufacturing (CMC)-Formulation

Label is not available on this site.

02/07/1995 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/19/1995 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

04/07/1995 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
03/03/2005 SUPPL-66 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20367s066lbl.pdf
11/13/2002 SUPPL-55 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20367slr055_Cerezyme_lbl.pdf
06/14/2002 SUPPL-53 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20367s53lbl.pdf

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