APPLICATION
NDA018285
TYPE
NDA
ORIGINAL APPROVAL
1982-09-03
LATEST ACTION
2007-10-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
VISKEN · ReferenceDiscontinued
PINDOLOL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
VISKEN · ReferenceDiscontinued
PINDOLOL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2001-04-02Manufacturing (CMC) · Supplement 33 · standardAP
1999-04-28Manufacturing (CMC) · Supplement 32 · standardAP
1999-02-24Manufacturing (CMC) · Supplement 31 · standardAP
1998-12-14Manufacturing (CMC) · Supplement 30 · standardAP
1998-10-15Manufacturing (CMC) · Supplement 29 · standardAP
1997-09-09Manufacturing (CMC) · Supplement 28 · standardAP
1995-11-02Manufacturing (CMC) · Supplement 27 · standardAP
1995-03-07Manufacturing (CMC) · Supplement 26 · standardAP
1993-12-15Manufacturing (CMC) · Supplement 25 · standardAP
1992-09-21Manufacturing (CMC) · Supplement 24 · standardAP
1992-08-19Labeling · Supplement 22AP
1992-01-14Manufacturing (CMC) · Supplement 23 · standardAP
1991-12-04Manufacturing (CMC) · Supplement 20 · standardAP
1991-09-03Manufacturing (CMC) · Supplement 21 · standardAP
1990-01-11Labeling · Supplement 17AP
1990-01-10Manufacturing (CMC) · Supplement 18 · standardAP
1989-10-26Manufacturing (CMC) · Supplement 14 · standardAP
1989-10-23Manufacturing (CMC) · Supplement 16 · standardAP
1989-05-01Labeling · Supplement 15AP
1988-10-27Manufacturing (CMC) · Supplement 13 · standardAP
1987-07-23Labeling · Supplement 12AP
1987-06-10Manufacturing (CMC) · Supplement 10 · standardAP
1986-07-08Labeling · Supplement 11AP
1986-02-20Manufacturing (CMC) · Supplement 8 · standardAP
1986-02-20Manufacturing (CMC) · Supplement 9 · standardAP
1985-07-16Manufacturing (CMC) · Supplement 7 · standardAP
1985-03-21Labeling · Supplement 5AP
1984-07-20Manufacturing (CMC) · Supplement 4 · standardAP
1983-06-02Efficacy · Supplement 3AP
1983-01-11Manufacturing (CMC) · Supplement 2 · standardAP
1982-11-05Labeling · Supplement 1AP
1982-09-03Type 1 - New Molecular Entity · 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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