APPLICATION
ANDA062752
TYPE
ANDA
ORIGINAL APPROVAL
1988-08-12
LATEST ACTION
2016-11-17
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
TETRACYCLINE HYDROCHLORIDEPrescription
TETRACYCLINE HYDROCHLORIDE 250MG · CAPSULE · ORAL
TETRACYCLINE HYDROCHLORIDEPrescription
TETRACYCLINE HYDROCHLORIDE 500MG · CAPSULE · ORAL
Approval history
2016-11-17Manufacturing (CMC) · Supplement 2 · unknownAP
1989-01-27Manufacturing (CMC) · Supplement 1AP
1988-08-12OriginalAP
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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