APPLICATION
NDA017048
TYPE
NDA
ORIGINAL APPROVAL
1974-07-26
LATEST ACTION
1996-11-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PEPTAVLON · ReferenceDiscontinued
PENTAGASTRIN 0.25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
1996-11-14Manufacturing (CMC) · Supplement 12 · priorityAP
1990-03-28Labeling · Supplement 10 · priorityAP
1989-08-21Manufacturing (CMC) · Supplement 11 · priorityAP
1988-12-12Labeling · Supplement 9 · priorityAP
1986-09-16Manufacturing (CMC) · Supplement 8 · priorityAP
1986-09-16Manufacturing (CMC) · Supplement 7 · priorityAP
1985-09-27Manufacturing (CMC) · Supplement 6 · priorityAP
1984-06-27Manufacturing (CMC) · Supplement 5 · priorityAP
1982-06-04Manufacturing (CMC) · Supplement 3 · priorityAP
1981-03-19Manufacturing (CMC) · Supplement 2 · priorityAP
1975-09-15Manufacturing (CMC) · Supplement 1 · priorityAP
1974-07-26Type 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.
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