Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 020367
Company: GENZYME
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 |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/12/2026 | SUPPL-123 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020367s123lbl.pdf | |
| 12/19/2024 | SUPPL-122 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020367s122lbl.pdf | |
| 12/19/2024 | SUPPL-122 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020367s122lbl.pdf | |
| 07/10/2024 | SUPPL-121 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020367s121lbl.pdf | |
| 12/22/2021 | SUPPL-119 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020367_S119lbl.pdf | |
| 12/22/2021 | SUPPL-119 | Labeling-Container/Carton Labels | 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 |