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FDA ANDA · ANDA081297

BENZONATATE

Sponsor: BIONPHARMA

APPLICATION
ANDA081297
TYPE
ANDA
ORIGINAL APPROVAL
1993-01-29
LATEST ACTION
2011-04-20
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

BENZONATATEPrescription
BENZONATATE 100MG · CAPSULE · ORAL
BENZONATATEPrescription
BENZONATATE 200MG · CAPSULE · ORAL

Approval history

2011-04-20Labeling · Supplement 23AP
2007-10-30Labeling · Supplement 16AP
2002-08-29Manufacturing (CMC) · Supplement 13AP
2002-08-29Manufacturing (CMC) · Supplement 11AP
2002-08-29Labeling · Supplement 14AP
2002-08-29Manufacturing (CMC) · Supplement 12AP
2002-08-29Manufacturing (CMC) · Supplement 10AP
2000-12-13Manufacturing (CMC) · Supplement 9AP
1997-10-30Manufacturing (CMC) · Supplement 8AP
1994-10-07Manufacturing (CMC) · Supplement 7AP
1994-05-03Manufacturing (CMC) · Supplement 5AP
1994-02-24Manufacturing (CMC) · Supplement 3AP
1994-02-24Manufacturing (CMC) · Supplement 4AP
1994-02-24Manufacturing (CMC) · Supplement 2AP
1993-12-23Manufacturing (CMC) · Supplement 1AP
1993-09-20Labeling · Supplement 6AP
1993-01-29OriginalAP
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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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