APPLICATION
ANDA060400
TYPE
ANDA
ORIGINAL APPROVAL
1957-06-21
LATEST ACTION
2025-03-31
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
SUMYCINDiscontinued
TETRACYCLINE HYDROCHLORIDE 125MG/5ML · SUSPENSION · ORAL
Approval history
2025-03-31Labeling · Supplement 8 · standardAP
2004-09-30Labeling · Supplement 7AP
1997-08-14Manufacturing (CMC) · Supplement 5AP
1997-07-16Labeling · Supplement 4AP
1957-06-21OriginalAP
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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