APPLICATION
BLA020580
TYPE
BLA
ORIGINAL APPROVAL
1996-12-09
LATEST ACTION
2000-10-12
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
COTAZYMDiscontinued
PANCRELIPASE (AMYLASE 30,000USP UNITS, LIPASE 8,000USP UNITS, PROTEASE) 30,000USP UNITS · CAPSULE · ORAL
Approval history
2000-10-12Manufacturing (CMC) · Supplement 1 · standardAP
1996-12-09Type 7 - Drug Already Marketed without Approved NDA · Original · standardAP
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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