APPLICATION
BLA018663
TYPE
BLA
ORIGINAL APPROVAL
1982-11-10
LATEST ACTION
1994-10-20
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CHYMODIACTINDiscontinued
CHYMOPAPAIN 4,000 UNITS/VIAL · INJECTABLE · INJECTION
CHYMODIACTINDiscontinued
CHYMOPAPAIN 10,000 UNITS/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** · INJECTABLE · INJECTION
Approval history
1994-10-20Manufacturing (CMC) · Supplement 27 · priorityAP
1994-06-15Manufacturing (CMC) · Supplement 28 · priorityAP
1994-05-24Manufacturing (CMC) · Supplement 29 · priorityAP
1993-10-28Labeling · Supplement 23AP
1993-05-19Labeling · Supplement 25AP
1991-10-02Manufacturing (CMC) · Supplement 24 · priorityAP
1989-11-28Manufacturing (CMC) · Supplement 22 · priorityAP
1988-07-07Manufacturing (CMC) · Supplement 21 · priorityAP
1987-07-01Manufacturing (CMC) · Supplement 16 · priorityAP
1987-01-15Labeling · Supplement 18AP
1986-12-15Manufacturing (CMC) · Supplement 19 · priorityAP
1986-07-18Labeling · Supplement 17AP
1985-07-18Labeling · Supplement 15AP
1984-08-21Manufacturing (CMC) · Supplement 11 · priorityAP
1984-08-21Labeling · Supplement 12AP
1984-07-18Manufacturing (CMC) · Supplement 8 · priorityAP
1984-07-18Manufacturing (CMC) · Supplement 6 · priorityAP
1984-07-09Manufacturing (CMC) · Supplement 3 · priorityAP
1984-07-09Manufacturing (CMC) · Supplement 1 · priorityAP
1984-04-06Labeling · Supplement 5AP
1984-04-06Labeling · Supplement 2AP
1982-11-10Type 1 - New Molecular Entity · Original · priorityAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.