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FDA ANDA · ANDA062055

ERYTHROMYCIN ETHYLSUCCINATE

Sponsor: ANI PHARMS

APPLICATION
ANDA062055
TYPE
ANDA
ORIGINAL APPROVAL
1978-11-27
LATEST ACTION
2018-11-02
ROUTE
ORAL
DOSAGE FORM
GRANULE
MARKETING STATUS
Prescription

Products

ERYTHROMYCIN ETHYLSUCCINATEPrescription
ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML · GRANULE · ORAL
ERYTHROMYCIN ETHYLSUCCINATEPrescription
ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML · GRANULE · ORAL
ERYTHROMYCIN ETHYLSUCCINATEPrescription
ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML · GRANULE · ORAL

Approval history

2018-11-02Manufacturing (CMC) · Supplement 35 · unknown — Review ↗AP
2018-11-02Manufacturing (CMC) · Supplement 34 · unknown — Review ↗AP
2014-04-25Labeling · Supplement 32 · standardAP
2001-06-01Labeling · Supplement 31AP
2001-05-24Manufacturing (CMC) · Supplement 30AP
2001-02-14Labeling · Supplement 29AP
1999-12-21Manufacturing (CMC) · Supplement 28AP
1999-05-20Manufacturing (CMC) · Supplement 27AP
1998-12-01Manufacturing (CMC) · Supplement 25AP
1998-10-08Labeling · Supplement 26AP
1998-09-25Manufacturing (CMC) · Supplement 24AP
1995-09-22Manufacturing (CMC) · Supplement 23AP
1994-12-23Manufacturing (CMC) · Supplement 22AP
1994-10-11Manufacturing (CMC) · Supplement 21AP
1993-07-01Labeling · Supplement 20AP
1992-04-29Manufacturing (CMC) · Supplement 15AP
1992-04-03Manufacturing (CMC) · Supplement 19AP
1992-04-03Manufacturing (CMC) · Supplement 17AP
1992-02-25Labeling · Supplement 16AP
1978-11-27OriginalAP
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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