APPLICATION
NDA016194
TYPE
NDA
ORIGINAL APPROVAL
1967-07-24
LATEST ACTION
2019-10-07
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
TALWIN · ReferenceDiscontinued
PENTAZOCINE LACTATE EQ 30MG BASE/ML · INJECTABLE · INJECTION
Approval history
2001-09-26Manufacturing (CMC) · Supplement 65 · priorityAP
2001-01-31Manufacturing (CMC) · Supplement 64 · priorityAP
2000-06-27Manufacturing (CMC) · Supplement 63 · priorityAP
2000-05-24Labeling · Supplement 62 · standardAP
1998-10-22Efficacy · Supplement 61 · standardAP
1995-10-10Manufacturing (CMC) · Supplement 60 · priorityAP
1993-04-21Manufacturing (CMC) · Supplement 59 · priorityAP
1992-09-29Manufacturing (CMC) · Supplement 58 · priorityAP
1990-01-25Manufacturing (CMC) · Supplement 57 · priorityAP
1989-09-22Manufacturing (CMC) · Supplement 55 · priorityAP
1989-08-23Labeling · Supplement 56AP
1988-05-04Manufacturing (CMC) · Supplement 53 · priorityAP
1988-03-30Labeling · Supplement 52AP
1985-07-15Manufacturing (CMC) · Supplement 49 · priorityAP
1983-09-01Manufacturing (CMC) · Supplement 47 · priorityAP
1983-08-24Manufacturing (CMC) · Supplement 48 · priorityAP
1983-05-18Labeling · Supplement 45AP
1981-10-09Labeling · Supplement 40AP
1981-09-29Labeling · Supplement 43AP
1981-08-07Manufacturing (CMC) · Supplement 42 · priorityAP
1981-03-18Manufacturing (CMC) · Supplement 44 · priorityAP
1980-11-05Manufacturing (CMC) · Supplement 41 · priorityAP
1979-04-09Labeling · Supplement 39AP
1978-09-14Labeling · Supplement 37AP
1978-07-21Labeling · Supplement 36AP
1978-07-18Manufacturing (CMC) · Supplement 38 · priorityAP
1978-02-22Labeling · Supplement 32AP
1977-12-16Manufacturing (CMC) · Supplement 34 · priorityAP
1977-12-15Manufacturing (CMC) · Supplement 31 · priorityAP
1977-12-02Manufacturing (CMC) · Supplement 33 · priorityAP
1977-01-04Manufacturing (CMC) · Supplement 35 · priorityAP
1976-07-16Labeling · Supplement 28AP
1976-06-07Manufacturing (CMC) · Supplement 30 · priorityAP
1976-03-26Manufacturing (CMC) · Supplement 18 · priorityAP
1976-03-26Manufacturing (CMC) · Supplement 27 · priorityAP
1975-10-23Labeling · Supplement 25AP
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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