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FDA ANDA · ANDA073609

PINDOLOL

Sponsor: ANI PHARMS

APPLICATION
ANDA073609
TYPE
ANDA
ORIGINAL APPROVAL
1993-03-29
LATEST ACTION
2002-04-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

PINDOLOLPrescription
PINDOLOL 10MG · TABLET · ORAL
PINDOLOLPrescription
PINDOLOL 5MG · TABLET · ORAL

Approval history

2002-04-19Manufacturing (CMC) · Supplement 12AP
2001-06-29Manufacturing (CMC) · Supplement 11AP
2001-06-07Manufacturing (CMC) · Supplement 10AP
2000-06-29Manufacturing (CMC) · Supplement 9AP
1999-05-05Manufacturing (CMC) · Supplement 8AP
1998-09-30Manufacturing (CMC) · Supplement 7AP
1996-11-27Manufacturing (CMC) · Supplement 6AP
1995-09-28Manufacturing (CMC) · Supplement 4AP
1995-09-28Manufacturing (CMC) · Supplement 5AP
1993-11-26Labeling · Supplement 3AP
1993-10-06Manufacturing (CMC) · Supplement 1AP
1993-06-28Labeling · Supplement 2AP
1993-03-29OriginalAP
VIEW ON DRUGS@FDA ↗

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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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