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FDA ANDA · ANDA060429

SUMYCIN

Sponsor: APOTHECON

APPLICATION
ANDA060429
TYPE
ANDA
ORIGINAL APPROVAL
1954-09-17
LATEST ACTION
1997-07-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

SUMYCINDiscontinued
TETRACYCLINE HYDROCHLORIDE 100MG · CAPSULE · ORAL
SUMYCINDiscontinued
TETRACYCLINE HYDROCHLORIDE 500MG · CAPSULE · ORAL
SUMYCINDiscontinued
TETRACYCLINE HYDROCHLORIDE 250MG · CAPSULE · ORAL
SUMYCINDiscontinued
TETRACYCLINE HYDROCHLORIDE 125MG · CAPSULE · ORAL

Approval history

1997-07-16Labeling · Supplement 9AP
1996-07-03Manufacturing (CMC) · Supplement 21AP
1995-11-01Manufacturing (CMC) · Supplement 20AP
1994-05-25Manufacturing (CMC) · Supplement 18AP
1992-10-06Manufacturing (CMC) · Supplement 16AP
1992-09-11Manufacturing (CMC) · Supplement 15AP
1991-05-23Manufacturing (CMC) · Supplement 13AP
1991-05-23Manufacturing (CMC) · Supplement 14AP
1989-09-15Manufacturing (CMC) · Supplement 8AP
1989-03-17Manufacturing (CMC) · Supplement 10AP
1987-04-01Manufacturing (CMC) · Supplement 7AP
1954-09-17OriginalAP
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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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