APPLICATION
NDA017821
TYPE
NDA
ORIGINAL APPROVAL
1977-08-26
LATEST ACTION
2013-04-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
FLEXERIL · ReferenceDiscontinued
CYCLOBENZAPRINE HYDROCHLORIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
FLEXERIL · ReferenceDiscontinued
CYCLOBENZAPRINE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2002-11-05Manufacturing (CMC) · Supplement 47 · priorityAP
2002-10-03Manufacturing (CMC) · Supplement 46 · priorityAP
1998-09-15Manufacturing (CMC) · Supplement 41 · priorityAP
1997-06-21Labeling · Supplement 24 · priorityAP
1996-11-29Manufacturing (CMC) · Supplement 40 · priorityAP
1996-03-01Manufacturing (CMC) · Supplement 39 · priorityAP
1994-08-18Manufacturing (CMC) · Supplement 37 · priorityAP
1994-06-09Manufacturing (CMC) · Supplement 32 · priorityAP
1990-01-10Manufacturing (CMC) · Supplement 33 · priorityAP
1988-04-08Manufacturing (CMC) · Supplement 31 · priorityAP
1986-05-30Labeling · Supplement 29 · priorityAP
1986-01-16Labeling · Supplement 26 · priorityAP
1984-02-24Manufacturing (CMC) · Supplement 25 · priorityAP
1983-06-21Manufacturing (CMC) · Supplement 19 · priorityAP
1983-01-04Manufacturing (CMC) · Supplement 23 · priorityAP
1982-06-03Labeling · Supplement 16 · priorityAP
1982-05-13Manufacturing (CMC) · Supplement 21 · priorityAP
1982-04-01Manufacturing (CMC) · Supplement 20 · priorityAP
1981-05-26Manufacturing (CMC) · Supplement 17 · priorityAP
1981-05-26Manufacturing (CMC) · Supplement 18 · priorityAP
1980-12-02Manufacturing (CMC) · Supplement 15 · priorityAP
1980-10-10Manufacturing (CMC) · Supplement 13 · priorityAP
1980-10-10Manufacturing (CMC) · Supplement 14 · priorityAP
1980-10-10Labeling · Supplement 12 · priorityAP
1980-08-21Manufacturing (CMC) · Supplement 11 · priorityAP
1979-05-31Labeling · Supplement 8 · priorityAP
1979-05-03Manufacturing (CMC) · Supplement 7 · priorityAP
1978-03-14Labeling · Supplement 2 · priorityAP
1978-03-02Labeling · Supplement 4 · priorityAP
1977-08-26Type 1 - New Molecular Entity · Original · priorityAP
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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