APPLICATION
ANDA080713
TYPE
ANDA
ORIGINAL APPROVAL
1973-01-18
LATEST ACTION
1999-04-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TRIPELENNAMINE HYDROCHLORIDEDiscontinued
TRIPELENNAMINE HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
1999-04-14Labeling · Supplement 36AP
1991-08-07Manufacturing (CMC) · Supplement 32AP
1991-01-28Manufacturing (CMC) · Supplement 33AP
1990-10-15Manufacturing (CMC) · Supplement 34AP
1990-10-15Manufacturing (CMC) · Supplement 30AP
1990-10-15Manufacturing (CMC) · Supplement 29AP
1989-11-21Labeling · Supplement 31AP
1986-01-08Manufacturing (CMC) · Supplement 28AP
1986-01-08Manufacturing (CMC) · Supplement 27AP
1983-12-28Manufacturing (CMC) · Supplement 26AP
1982-04-28Manufacturing (CMC) · Supplement 24AP
1982-04-28Manufacturing (CMC) · Supplement 25AP
1973-01-18OriginalAP
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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