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FDA NDA · NDA050536

ERYTHROMYCIN

Sponsor: DR REDDYS LABS SA

APPLICATION
NDA050536
TYPE
NDA
ORIGINAL APPROVAL
1981-01-26
LATEST ACTION
2018-04-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE, DELAYED REL PELLETS
MARKETING STATUS
Prescription

Products

ERYC · ReferencePrescription
ERYTHROMYCIN 250MG · CAPSULE, DELAYED REL PELLETS · ORAL

Approval history

2018-04-23Labeling · Supplement 26 · standard — Label ↗AP
2013-12-19Manufacturing (CMC) · Supplement 24 · standardAP
2013-12-19Manufacturing (CMC) · Supplement 23 · standardAP
2013-03-21Labeling · Supplement 21 · standard — Letter ↗AP
2012-02-14Labeling · Supplement 22 · standard — Label ↗AP
2008-02-21Labeling · Supplement 20 · standard — Letter ↗AP
2006-01-12Labeling · Supplement 19 · standard — Label ↗AP
2004-02-02Labeling · Supplement 16 · standard — Letter ↗AP
2003-12-18Labeling · Supplement 18 · standard — Letter ↗AP
2000-09-22Labeling · Supplement 13 · standardAP
1999-08-05Manufacturing (CMC) · Supplement 15 · standardAP
1997-10-21Manufacturing (CMC) · Supplement 14 · standardAP
1986-06-16Manufacturing (CMC) · Supplement 7 · standardAP
1982-03-30Manufacturing (CMC) · Supplement 12 · standardAP
1982-01-28Manufacturing (CMC) · Supplement 11 · standardAP
1981-08-07Labeling · Supplement 10AP
1981-06-15Labeling · Supplement 9AP
1981-06-05Manufacturing (CMC) · Supplement 8 · standardAP
1981-06-05Labeling · Supplement 6AP
1981-05-21Labeling · Supplement 3AP
1981-05-20Manufacturing (CMC) · Supplement 5 · standardAP
1981-05-18Manufacturing (CMC) · Supplement 4 · standardAP
1981-04-22Manufacturing (CMC) · Supplement 2 · standardAP
1981-01-26Type 3 - New Dosage Form · Original · standardAP
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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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