APPLICATION
ANDA086576
TYPE
ANDA
ORIGINAL APPROVAL
1979-11-30
LATEST ACTION
2000-11-13
ROUTE
NASAL
DOSAGE FORM
SOLUTION, SPRAY
MARKETING STATUS
Prescription
Products
TYZINEPrescription
TETRAHYDROZOLINE HYDROCHLORIDE 0.05% · SOLUTION · NASAL
TYZINEPrescription
TETRAHYDROZOLINE HYDROCHLORIDE 0.1% · SPRAY · NASAL
TYZINEPrescription
TETRAHYDROZOLINE HYDROCHLORIDE 0.1% · SOLUTION · NASAL
Approval history
2000-11-13Manufacturing (CMC) · Supplement 15AP
2000-11-13Manufacturing (CMC) · Supplement 16AP
2000-11-13Manufacturing (CMC) · Supplement 14AP
2000-11-13Labeling · Supplement 17AP
1993-07-23Manufacturing (CMC) · Supplement 13AP
1993-07-23Manufacturing (CMC) · Supplement 11AP
1993-07-23Manufacturing (CMC) · Supplement 12AP
1993-07-23Labeling · Supplement 10AP
1993-07-23Manufacturing (CMC) · Supplement 9AP
1990-09-20Manufacturing (CMC) · Supplement 7AP
1989-07-12Labeling · Supplement 6AP
1986-02-05Manufacturing (CMC) · Supplement 4AP
1984-10-19Manufacturing (CMC) · Supplement 1AP
1984-10-19Manufacturing (CMC) · Supplement 3AP
1979-11-30OriginalAP
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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