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 is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/20/2020 | SUPPL-5 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
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. |
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