← FDA DRUG APPROVALS

FDA BLA · BLA022542

VIOKACE

pancrelipase

Sponsor: VIOKACE

APPLICATION
BLA022542
TYPE
BLA
ORIGINAL APPROVAL
2012-03-01
LATEST ACTION
2024-02-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

VIOKACEPrescription
PANCRELIPASE (AMYLASE 39,150USP UNITS, LIPASE 10,440USP UNITS, PROTEASE) 39,150USP UNITS · TABLET · ORAL
VIOKACEPrescription
PANCRELIPASE (AMYLASE 78,300USP UNITS, LIPASE 20,880USP UNITS, PROTEASE) 78,300USP UNITS · TABLET · ORAL

Approval history

2024-02-28Labeling · Supplement 9 · standard — Letter ↗AP
2023-11-20Manufacturing (CMC) · Supplement 10 — Review ↗AP
2022-10-21Manufacturing (CMC) · Supplement 8 — Review ↗AP
2022-09-28Labeling · Supplement 7 · standard — Label ↗AP
2020-03-20Labeling · Supplement 5 · standard — Label ↗AP
2014-07-29Manufacturing (CMC) · Supplement 6 — Review ↗AP
2014-07-29Manufacturing (CMC) · Supplement 2 · standardAP
2014-01-06Manufacturing (CMC) · Supplement 1 · standardAP
2012-03-01Type 7 - Drug Already Marketed without Approved NDA · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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