APPLICATION
ANDA074063
TYPE
ANDA
ORIGINAL APPROVAL
1994-01-27
LATEST ACTION
2015-03-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
PINDOLOLPrescription
PINDOLOL 10MG · TABLET · ORAL
PINDOLOLPrescription
PINDOLOL 5MG · TABLET · ORAL
Approval history
2015-03-09Manufacturing (CMC) · Supplement 17 · unknownAP
2002-12-02Manufacturing (CMC) · Supplement 8AP
2001-02-15Manufacturing (CMC) · Supplement 7AP
2000-05-16Manufacturing (CMC) · Supplement 5AP
2000-05-16Manufacturing (CMC) · Supplement 6AP
1997-12-05Manufacturing (CMC) · Supplement 4AP
1997-02-24Manufacturing (CMC) · Supplement 3AP
1996-04-17Manufacturing (CMC) · Supplement 2AP
1995-06-22Manufacturing (CMC) · Supplement 1AP
1994-01-27OriginalAP
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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