APPLICATION
NDA016732
TYPE
NDA
ORIGINAL APPROVAL
1969-02-03
LATEST ACTION
1982-04-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TALWIN 50Discontinued
PENTAZOCINE HYDROCHLORIDE EQ 50MG BASE · TABLET · ORAL
Approval history
1982-04-19Manufacturing (CMC) · Supplement 51 · priorityAP
1981-10-02Labeling · Supplement 47 · priorityAP
1981-01-09Manufacturing (CMC) · Supplement 46 · priorityAP
1980-10-02Manufacturing (CMC) · Supplement 45 · priorityAP
1980-08-19Manufacturing (CMC) · Supplement 44 · priorityAP
1979-09-05Labeling · Supplement 43 · priorityAP
1979-07-23Labeling · Supplement 42 · priorityAP
1979-05-31Labeling · Supplement 41 · priorityAP
1979-04-30Labeling · Supplement 40 · priorityAP
1979-04-11Labeling · Supplement 39 · priorityAP
1978-11-28Manufacturing (CMC) · Supplement 37 · priorityAP
1978-11-06Manufacturing (CMC) · Supplement 38 · priorityAP
1977-11-28Manufacturing (CMC) · Supplement 36 · priorityAP
1977-08-30Labeling · Supplement 35 · priorityAP
1977-05-11Manufacturing (CMC) · Supplement 34 · priorityAP
1976-07-16Labeling · Supplement 33 · priorityAP
1975-10-31Labeling · Supplement 30 · priorityAP
1975-07-30Manufacturing (CMC) · Supplement 29 · priorityAP
1975-07-30Manufacturing (CMC) · Supplement 28 · priorityAP
1975-04-03Manufacturing (CMC) · Supplement 27 · priorityAP
1974-12-09Labeling · Supplement 25 · priorityAP
1974-11-08Labeling · Supplement 22 · priorityAP
1974-09-26Labeling · Supplement 26 · priorityAP
1969-02-03Type 2 - New Active Ingredient · 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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