APPLICATION
NDA016891
TYPE
NDA
ORIGINAL APPROVAL
1975-11-12
LATEST ACTION
1996-07-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TALWIN COMPOUND · ReferenceDiscontinued
ASPIRIN 325MG, PENTAZOCINE HYDROCHLORIDE EQ 12.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
1996-07-25Manufacturing (CMC) · Supplement 19 · standardAP
1995-11-29Manufacturing (CMC) · Supplement 20 · standardAP
1991-01-03Labeling · Supplement 18 · standardAP
1989-01-05Labeling · Supplement 16 · standardAP
1989-01-05Labeling · Supplement 9 · standardAP
1989-01-05Labeling · Supplement 15 · standardAP
1988-03-17Manufacturing (CMC) · Supplement 17 · standardAP
1982-03-09Manufacturing (CMC) · Supplement 14 · standardAP
1981-12-01Manufacturing (CMC) · Supplement 13 · standardAP
1981-10-02Labeling · Supplement 11 · standardAP
1980-11-05Manufacturing (CMC) · Supplement 10 · standardAP
1979-05-30Manufacturing (CMC) · Supplement 8 · standardAP
1979-05-08Manufacturing (CMC) · Supplement 6 · standardAP
1979-05-08Manufacturing (CMC) · Supplement 7 · standardAP
1979-05-08Manufacturing (CMC) · Supplement 3 · standardAP
1977-12-09Manufacturing (CMC) · Supplement 4 · standardAP
1977-05-13Labeling · Supplement 2 · standardAP
1976-02-23Manufacturing (CMC) · Supplement 1 · standardAP
1975-11-12Type 4 - New Combination · 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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