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FDA ANDA · ANDA064126

ERY

erythromycin

Sponsor: PADAGIS US

APPLICATION
ANDA064126
TYPE
ANDA
ORIGINAL APPROVAL
1996-07-03
LATEST ACTION
2008-03-31
ROUTE
TOPICAL
DOSAGE FORM
SWAB
MARKETING STATUS
Prescription

Products

ERYTHROMYCINPrescription
ERYTHROMYCIN 2% · SWAB · TOPICAL

Approval history

2008-03-31Labeling · Supplement 9AP
2002-09-16Manufacturing (CMC) · Supplement 6AP
2002-02-20Manufacturing (CMC) · Supplement 3AP
2001-12-06Manufacturing (CMC) · Supplement 4AP
2001-12-06Manufacturing (CMC) · Supplement 5AP
2000-11-17Manufacturing (CMC) · Supplement 2AP
1997-07-11Labeling · Supplement 1AP
1996-07-03OriginalReviewAP
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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