Drugs@FDA: FDA-Approved Drugs
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 | No | No |
| CEREZYME | IMIGLUCERASE | 400 UNITS/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 |
|---|---|---|---|---|---|---|---|
| 05/23/1994 | 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 |
|---|---|---|---|---|---|
| 12/22/2021 | SUPPL-119 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020367_S119lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020367Orig1s119ltr.pdf | |
| 07/22/2016 | SUPPL-101 | Supplement |
Label is not available on this site. |
||
| 07/07/2016 | SUPPL-99 | Supplement |
Label is not available on this site. |
||
| 06/08/2016 | SUPPL-98 | Supplement |
Label is not available on this site. |
||
| 04/21/2016 | SUPPL-97 | Supplement |
Label is not available on this site. |
||
| 03/03/2016 | SUPPL-96 | Supplement |
Label is not available on this site. |
||
| 10/30/2015 | SUPPL-95 | Supplement |
Label is not available on this site. |
||
| 08/10/2015 | SUPPL-94 | Supplement |
Label is not available on this site. |
||
| 03/09/2015 | SUPPL-92 | Supplement |
Label is not available on this site. |
||
| 09/05/2014 | SUPPL-91 | Supplement |
Label is not available on this site. |
||
| 02/27/2014 | SUPPL-90 | Supplement |
Label is not available on this site. |
||
| 10/30/2013 | SUPPL-89 | Supplement |
Label is not available on this site. |
||
| 07/31/2013 | SUPPL-88 | Supplement |
Label is not available on this site. |
||
| 03/03/2005 | SUPPL-66 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
| 11/13/2002 | SUPPL-55 | Supplement |
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 | Supplement |
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 | Supplement |
Label is not available on this site. |
||
| 05/07/2001 | SUPPL-50 | Supplement |
Label is not available on this site. |
||
| 08/13/2001 | SUPPL-49 | Supplement |
Label is not available on this site. |
||
| 11/14/2000 | SUPPL-48 | Supplement |
Label is not available on this site. |
||
| 10/27/2000 | SUPPL-47 | Supplement |
Label is not available on this site. |
||
| 08/31/2000 | SUPPL-46 | Supplement |
Label is not available on this site. |
||
| 09/11/2000 | SUPPL-45 | Supplement |
Label is not available on this site. |
||
| 07/10/2000 | SUPPL-44 | Supplement |
Label is not available on this site. |
||
| 04/10/2000 | SUPPL-43 | Supplement |
Label is not available on this site. |
||
| 08/13/2001 | SUPPL-42 | Supplement |
Label is not available on this site. |
||
| 08/13/2001 | SUPPL-41 | Supplement |
Label is not available on this site. |
||
| 12/08/1999 | SUPPL-40 | Supplement |
Label is not available on this site. |
||
| 09/07/1999 | SUPPL-39 | Supplement |
Label is not available on this site. |
||
| 10/22/1999 | SUPPL-38 | Supplement |
Label is not available on this site. |
||
| 10/05/1999 | SUPPL-37 | Supplement |
Label is not available on this site. |
||
| 07/28/1999 | SUPPL-36 | Supplement |
Label is not available on this site. |
||
| 07/26/1999 | SUPPL-35 | Supplement |
Label is not available on this site. |
||
| 09/22/1999 | SUPPL-34 | Supplement |
Label is not available on this site. |
||
| 01/04/1999 | SUPPL-33 | Supplement |
Label is not available on this site. |
||
| 11/18/1998 | SUPPL-32 | Supplement |
Label is not available on this site. |
||
| 06/17/1998 | SUPPL-31 | Supplement |
Label is not available on this site. |
||
| 06/12/1998 | SUPPL-30 | Supplement |
Label is not available on this site. |
||
| 06/12/1998 | SUPPL-29 | Supplement |
Label is not available on this site. |
||
| 03/23/1998 | SUPPL-28 | Supplement |
Label is not available on this site. |
||
| 02/11/1999 | SUPPL-27 | Supplement |
Label is not available on this site. |
||
| 01/30/1998 | SUPPL-26 | Supplement |
Label is not available on this site. |
||
| 08/08/1997 | SUPPL-25 | Supplement |
Label is not available on this site. |
||
| 07/31/1997 | SUPPL-24 | Supplement |
Label is not available on this site. |
||
| 07/16/1997 | SUPPL-23 | Supplement |
Label is not available on this site. |
||
| 12/20/1996 | SUPPL-21 | Supplement |
Label is not available on this site. |
||
| 03/03/1997 | SUPPL-20 | Supplement |
Label is not available on this site. |
||
| 09/23/1996 | SUPPL-18 | Supplement |
Label is not available on this site. |
||
| 12/12/1996 | SUPPL-17 | Supplement |
Label is not available on this site. |
||
| 10/22/1996 | SUPPL-16 | Supplement |
Label is not available on this site. |
||
| 09/20/1996 | SUPPL-15 | Supplement |
Label is not available on this site. |
||
| 06/05/1996 | SUPPL-13 | Supplement |
Label is not available on this site. |
||
| 04/08/1996 | SUPPL-12 | Supplement |
Label is not available on this site. |
||
| 02/23/1996 | SUPPL-11 | Supplement |
Label is not available on this site. |
||
| 05/31/1996 | SUPPL-10 | Supplement |
Label is not available on this site. |
||
| 12/06/1995 | SUPPL-9 | Supplement |
Label is not available on this site. |
||
| 04/18/1996 | SUPPL-8 | Supplement |
Label is not available on this site. |
||
| 07/24/1995 | SUPPL-7 | Supplement |
Label is not available on this site. |
||
| 12/07/1997 | SUPPL-6 | Supplement |
Label is not available on this site. |
||
| 05/03/1995 | SUPPL-5 | Supplement |
Label is not available on this site. |
||
| 05/08/1995 | SUPPL-4 | Supplement |
Label is not available on this site. |
||
| 02/07/1995 | SUPPL-3 | Supplement |
Label is not available on this site. |
||
| 06/19/1995 | SUPPL-2 | Supplement |
Label is not available on this site. |
||
| 04/07/1995 | SUPPL-1 | Supplement |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/22/2021 | SUPPL-119 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020367_S119lbl.pdf | |
| 12/22/2021 | SUPPL-119 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020367_S119lbl.pdf | |
| 03/03/2005 | SUPPL-66 | Manufacturing (CMC) | Label (PDF) | 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 |