← FDA DRUG APPROVALS

FDA NDA · NDA012157

NORFLEX

Sponsor: BAUSCH

APPLICATION
NDA012157
TYPE
NDA
ORIGINAL APPROVAL
1959-11-04
LATEST ACTION
2007-04-02
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

NORFLEX · ReferenceDiscontinued
ORPHENADRINE CITRATE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL

Approval history

2007-04-02Labeling · Supplement 28 · standard — Letter ↗AP
1997-09-12Manufacturing (CMC) · Supplement 27 · standardAP
1996-04-16Manufacturing (CMC) · Supplement 26 · standardAP
1995-05-11Labeling · Supplement 22AP
1994-10-11Manufacturing (CMC) · Supplement 25 · standardAP
1989-03-13Manufacturing (CMC) · Supplement 23 · standardAP
1988-07-26Manufacturing (CMC) · Supplement 24 · standardAP
1980-08-26Manufacturing (CMC) · Supplement 15 · standardAP
1980-07-21Manufacturing (CMC) · Supplement 14 · standardAP
1978-03-13Manufacturing (CMC) · Supplement 13 · standardAP
1975-11-03Labeling · Supplement 12AP
1959-11-04Type 2 - New Active Ingredient · Original · standardAP
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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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