← FDA DRUG APPROVALS

FDA ANDA · ANDA061621

ERYTHROMYCIN

Sponsor: CARNEGIE

APPLICATION
ANDA061621
TYPE
ANDA
ORIGINAL APPROVAL
1972-07-11
LATEST ACTION
2019-10-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ERYTHROMYCINPrescription
ERYTHROMYCIN 250MG · TABLET · ORAL
ERYTHROMYCINPrescription
ERYTHROMYCIN 500MG · TABLET · ORAL

Approval history

2019-10-11Labeling · Supplement 43 · standard — Letter ↗AP
2013-12-04Labeling · Supplement 39 · standard — Label ↗AP
2013-07-24Labeling · Supplement 40 · standardAP
2009-09-24Labeling · Supplement 38AP
2009-07-02Labeling · Supplement 37AP
2006-07-03Labeling · Supplement 35AP
2004-03-17Labeling · Supplement 33AP
2000-07-26Manufacturing (CMC) · Supplement 28AP
2000-07-26Manufacturing (CMC) · Supplement 26AP
2000-07-26Labeling · Supplement 24AP
2000-07-26Labeling · Supplement 27AP
2000-07-26Manufacturing (CMC) · Supplement 25AP
2000-07-18Manufacturing (CMC) · Supplement 29AP
1998-04-20Manufacturing (CMC) · Supplement 23AP
1972-07-11Original — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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