Drugs@FDA: FDA-Approved Drugs
Company: QOL MEDCL
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SUCRAID | SACROSIDASE | 8,500 IU/ML | SOLUTION;ORAL | 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 |
---|---|---|---|---|---|---|---|
04/09/1998 | ORIG-1 | Approval | N/A; Orphan |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20772ap_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20772.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/02/2024 | SUPPL-31 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020772s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020772Orig1s031ltr.pdf | |
07/24/2024 | SUPPL-30 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020772s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020772Orig1s030ltr.pdf | |
05/25/2022 | SUPPL-27 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020772Orig1s027Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020772Orig1s027ltr.pdf | |
09/21/2015 | SUPPL-20 | Supplement |
Label is not available on this site. |
||
02/16/2015 | SUPPL-19 | Supplement |
Label is not available on this site. |
||
12/02/2014 | SUPPL-17 | Supplement |
Label is not available on this site. |
||
11/07/2014 | SUPPL-15 | Supplement |
Label is not available on this site. |
||
05/28/2013 | SUPPL-13 | Supplement |
Label is not available on this site. |
||
12/09/2010 | SUPPL-11 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020772s011ltr.pdf |
06/15/2011 | SUPPL-8 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020772s008ltr.pdf |
11/20/2008 | SUPPL-7 | Supplement |
Label is not available on this site. |
||
11/20/2008 | SUPPL-6 | Supplement |
Label is not available on this site. |
||
11/20/2008 | SUPPL-5 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020772s005ltr.pdf |
02/20/2008 | SUPPL-4 | Supplement |
Label is not available on this site. |
||
11/03/2006 | SUPPL-2 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020772s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
08/02/2024 | SUPPL-31 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020772s031lbl.pdf | |
07/24/2024 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020772s030lbl.pdf | |
05/25/2022 | SUPPL-27 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020772Orig1s027Lbl.pdf |