Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 022542
Company: VIOKACE
Company: VIOKACE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VIOKACE | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | 39,150USP UNITS;10,440USP UNITS;39,150USP UNITS | TABLET;ORAL | Prescription | None | No | No |
VIOKACE | PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) | 78,300USP UNITS;20,880USP UNITS;78,300USP UNITS | TABLET;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 |
---|---|---|---|---|---|---|---|
03/01/2012 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022542s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022542s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022542_viokace_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022542Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/20/2023 | SUPPL-10 | Supplement |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drusgsatfda_docs/nda/2024/022542Orig1s010.pdf |
02/28/2024 | SUPPL-9 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022542s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022542Orig1s009ltr.pdf | |
10/21/2022 | SUPPL-8 | Supplement |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/022542Orig1s008.pdf |
09/28/2022 | SUPPL-7 | Supplement |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022542Orig1s007CorrectedLbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022542Orig1s007CorrectedLtr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/022542Orig1s007.pdf | |
07/29/2014 | SUPPL-6 | Supplement |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/022542Orig1s006.pdf |
03/20/2020 | SUPPL-5 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022542s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022542Orig1s005ltr.pdf | |
07/29/2014 | SUPPL-2 | Supplement |
Label is not available on this site. |
||
01/06/2014 | 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 |
---|---|---|---|---|---|
02/28/2024 | SUPPL-9 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022542s009lbl.pdf | |
02/28/2024 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022542s009lbl.pdf | |
09/28/2022 | SUPPL-7 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022542Orig1s007CorrectedLbl.pdf | |
09/28/2022 | SUPPL-7 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022542Orig1s007CorrectedLbl.pdf | |
09/28/2022 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022542Orig1s007CorrectedLbl.pdf | |
03/20/2020 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022542s005lbl.pdf | |
03/20/2020 | SUPPL-5 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022542s005lbl.pdf | |
03/01/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022542s000lbl.pdf |