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FDA ANDA · ANDA211975

ERYTHROMYCIN

Sponsor: TORRENT

APPLICATION
ANDA211975
TYPE
ANDA
ORIGINAL APPROVAL
2021-07-26
LATEST ACTION
2024-08-13
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

ERYTHROMYCINPrescription
ERYTHROMYCIN 333MG · TABLET, DELAYED RELEASE · ORAL
ERYTHROMYCINPrescription
ERYTHROMYCIN 250MG · TABLET, DELAYED RELEASE · ORAL
ERYTHROMYCINPrescription
ERYTHROMYCIN 500MG · TABLET, DELAYED RELEASE · ORAL

Approval history

2024-08-13Manufacturing (CMC) · Supplement 6 · unknown — Letter ↗AP
2021-07-26UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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