FDA NDA · NDA050557

BENZAMYCIN

erythromycin and benzoyl peroxide

Sponsor: VALEANT INTL

APPLICATION

NDA050557

TYPE

NDA

ORIGINAL APPROVAL

1984-10-26

LATEST ACTION

2014-12-05

ROUTE

TOPICAL

DOSAGE FORM

GEL

MARKETING STATUS

Prescription

Products

BENZAMYCIN · ReferencePrescription

BENZOYL PEROXIDE 5%, ERYTHROMYCIN 3% · GEL · TOPICAL

2014-12-05Manufacturing (CMC) · Supplement 38 · standardAP

2003-01-27Manufacturing (CMC) · Supplement 25 · standard — Label ↗AP

2002-08-28Manufacturing (CMC) · Supplement 24 · standardAP

2002-03-21Manufacturing (CMC) · Supplement 23 · standardAP

2001-04-17Manufacturing (CMC) · Supplement 22 · standardAP

2001-02-06Manufacturing (CMC) · Supplement 21 · standardAP

2000-09-27Manufacturing (CMC) · Supplement 20 · standardAP

1997-06-11Manufacturing (CMC) · Supplement 19 · standardAP

1996-03-05Labeling · Supplement 18 · standardAP

1995-06-08Labeling · Supplement 17 · standardAP

1994-10-21Labeling · Supplement 15AP

1993-04-13Manufacturing (CMC) · Supplement 13 · standardAP

1993-04-07Manufacturing (CMC) · Supplement 14 · standardAP

1989-09-15Manufacturing (CMC) · Supplement 12 · standardAP

1984-10-26Type 4 - New Combination · Original · standardAP

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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