APPLICATION
NDA050451
TYPE
NDA
ORIGINAL APPROVAL
1982-08-10
LATEST ACTION
1995-08-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
MINOCYCLINE HYDROCHLORIDE · ReferenceDiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
MINOCYCLINE HYDROCHLORIDE · ReferenceDiscontinued
MINOCYCLINE HYDROCHLORIDE EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
1995-08-08Labeling · Supplement 25 · standardAP
1992-05-12Labeling · Supplement 23 · standardAP
1989-03-30Manufacturing (CMC) · Supplement 21 · standardAP
1987-10-06Labeling · Supplement 15 · standardAP
1986-12-01Manufacturing (CMC) · Supplement 9 · standardAP
1986-10-29Labeling · Supplement 10 · standardAP
1986-10-08Manufacturing (CMC) · Supplement 13 · standardAP
1986-06-27Manufacturing (CMC) · Supplement 11 · standardAP
1985-01-29Manufacturing (CMC) · Supplement 8 · standardAP
1984-03-23Manufacturing (CMC) · Supplement 7 · standardAP
1983-12-16Manufacturing (CMC) · Supplement 6 · standardAP
1983-08-25Manufacturing (CMC) · Supplement 5 · standardAP
1983-05-05Labeling · Supplement 3 · standardAP
1983-04-27Manufacturing (CMC) · Supplement 1 · standardAP
1983-04-27Manufacturing (CMC) · Supplement 2 · standardAP
1982-08-10Type 5 - New Formulation or New Manufacturer · 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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