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FDA ANDA · ANDA084442

PROBENECID

Sponsor: WATSON LABS TEVA

APPLICATION
ANDA084442
TYPE
ANDA
ORIGINAL APPROVAL
1977-03-02
LATEST ACTION
2002-04-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

PROBENECIDPrescription
PROBENECID 500MG · TABLET · ORAL

Approval history

2002-04-29Manufacturing (CMC) · Supplement 51AP
2001-04-25Manufacturing (CMC) · Supplement 50AP
2000-10-16Manufacturing (CMC) · Supplement 49AP
1993-11-05Manufacturing (CMC) · Supplement 46AP
1991-08-07Manufacturing (CMC) · Supplement 44AP
1991-01-28Manufacturing (CMC) · Supplement 45AP
1990-06-29Manufacturing (CMC) · Supplement 43AP
1989-04-17Labeling · Supplement 41AP
1988-11-15Manufacturing (CMC) · Supplement 38AP
1988-11-15Manufacturing (CMC) · Supplement 40AP
1985-06-03Manufacturing (CMC) · Supplement 35AP
1985-06-03Manufacturing (CMC) · Supplement 34AP
1985-01-15Manufacturing (CMC) · Supplement 33AP
1984-02-16Manufacturing (CMC) · Supplement 32AP
1983-03-29Manufacturing (CMC) · Supplement 29AP
1983-03-29Manufacturing (CMC) · Supplement 31AP
1977-03-02OriginalAP
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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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