APPLICATION
NDA050493
TYPE
NDA
ORIGINAL APPROVAL
1977-09-21
LATEST ACTION
1997-10-17
ROUTE
TOPICAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Discontinued
Products
TOPICYCLINEDiscontinued
TETRACYCLINE HYDROCHLORIDE 2.2MG/ML · FOR SOLUTION · TOPICAL
Approval history
1997-10-17Manufacturing (CMC) · Supplement 32 · standardAP
1997-09-23Manufacturing (CMC) · Supplement 31 · standardAP
1986-05-19Manufacturing (CMC) · Supplement 4 · standardAP
1986-03-27Labeling · Supplement 29 · standardAP
1983-03-24Manufacturing (CMC) · Supplement 1 · standardAP
1983-01-17Manufacturing (CMC) · Supplement 28 · standardAP
1982-06-22Labeling · Supplement 27 · standardAP
1982-05-05Manufacturing (CMC) · Supplement 23 · standardAP
1981-12-01Manufacturing (CMC) · Supplement 26 · standardAP
1981-10-30Labeling · Supplement 25 · standardAP
1981-08-10Manufacturing (CMC) · Supplement 24 · standardAP
1981-02-13Labeling · Supplement 22 · standardAP
1981-02-02Manufacturing (CMC) · Supplement 21 · standardAP
1980-10-20Manufacturing (CMC) · Supplement 20 · standardAP
1979-08-22Manufacturing (CMC) · Supplement 19 · standardAP
1979-05-03Manufacturing (CMC) · Supplement 18 · standardAP
1979-03-28Manufacturing (CMC) · Supplement 16 · standardAP
1979-03-13Labeling · Supplement 17 · standardAP
1979-02-26Manufacturing (CMC) · Supplement 15 · standardAP
1978-08-10Manufacturing (CMC) · Supplement 14 · standardAP
1978-07-25Manufacturing (CMC) · Supplement 13 · standardAP
1978-06-16Labeling · Supplement 8 · standardAP
1978-04-24Labeling · Supplement 10 · standardAP
1978-04-24Manufacturing (CMC) · Supplement 11 · standardAP
1978-04-11Manufacturing (CMC) · Supplement 9 · standardAP
1978-01-24Manufacturing (CMC) · Supplement 7 · standardAP
1978-01-11Manufacturing (CMC) · Supplement 6 · standardAP
1977-12-27Manufacturing (CMC) · Supplement 2 · standardAP
1977-09-21Type 3 - New Dosage Form · 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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