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FDA ANDA · ANDA061471

TETRACYCLINE HYDROCHLORIDE

Sponsor: ANI PHARMS

APPLICATION
ANDA061471
TYPE
ANDA
ORIGINAL APPROVAL
1994-09-16
LATEST ACTION
1995-01-31
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

TETRACYCLINE HYDROCHLORIDEDiscontinued
TETRACYCLINE HYDROCHLORIDE 250MG · CAPSULE · ORAL

Approval history

1995-01-31Manufacturing (CMC) · Supplement 16AP
1995-01-31Manufacturing (CMC) · Supplement 17AP
1994-09-16OriginalAP
1993-07-26Labeling · Supplement 15AP
1993-04-27Labeling · Supplement 14AP
1988-09-06Manufacturing (CMC) · Supplement 8AP
VIEW ON DRUGS@FDA ↗

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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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