APPLICATION
NDA011210
TYPE
NDA
ORIGINAL APPROVAL
1958-02-10
LATEST ACTION
2011-01-20
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued, Prescription
Products
TESSALON · ReferenceDiscontinued
BENZONATATE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
TESSALON · ReferencePrescription
BENZONATATE 100MG · CAPSULE · ORAL
Approval history
2002-07-23Manufacturing (CMC) · Supplement 41 · standardAP
2000-11-01Manufacturing (CMC) · Supplement 40 · standardAP
2000-06-30Manufacturing (CMC) · Supplement 39 · standardAP
1999-06-25Manufacturing (CMC) · Supplement 35 · standardAP
1999-06-08Manufacturing (CMC) · Supplement 37 · standardAP
1993-12-01Manufacturing (CMC) · Supplement 32 · standardAP
1992-09-04Labeling · Supplement 31AP
1986-10-08Labeling · Supplement 30AP
1985-11-29Labeling · Supplement 29AP
1985-11-29Labeling · Supplement 25AP
1985-11-05Manufacturing (CMC) · Supplement 27 · standardAP
1985-06-13Manufacturing (CMC) · Supplement 26 · standardAP
1981-07-15Manufacturing (CMC) · Supplement 22 · standardAP
1980-07-03Manufacturing (CMC) · Supplement 21 · standardAP
1979-08-28Manufacturing (CMC) · Supplement 20 · standardAP
1979-07-06Manufacturing (CMC) · Supplement 19 · standardAP
1978-10-24Manufacturing (CMC) · Supplement 14 · standardAP
1978-09-29Labeling · Supplement 18AP
1978-09-29Manufacturing (CMC) · Supplement 15 · standardAP
1975-03-31Manufacturing (CMC) · Supplement 13 · standardAP
1974-12-30Supplement · Supplement 11 · standardAP
1972-04-12Labeling · Supplement 2AP
1958-02-10Type 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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