Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050557
Company: VALEANT INTL

Products on NDA 050557

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BENZAMYCIN	BENZOYL PEROXIDE; ERYTHROMYCIN	5%;3%	GEL;TOPICAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050557

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/26/1984	ORIG-1	Approval	Type 4 - New Combination	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/05/2014	SUPPL-38	Manufacturing (CMC)		Label is not available on this site.
01/27/2003	SUPPL-25	Manufacturing (CMC)-Formulation	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050557s025lbl.pdf
08/28/2002	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
03/21/2002	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
04/17/2001	SUPPL-22	Manufacturing (CMC)-Control		Label is not available on this site.
02/06/2001	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
09/27/2000	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
06/11/1997	SUPPL-19	Manufacturing (CMC)-Formulation		Label is not available on this site.
03/05/1996	SUPPL-18	Labeling		Label is not available on this site.
06/08/1995	SUPPL-17	Labeling		Label is not available on this site.
10/21/1994	SUPPL-15	Labeling		Label is not available on this site.
04/07/1993	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
04/13/1993	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
09/15/1989	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 050557

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/27/2003	SUPPL-25	Manufacturing (CMC)-Formulation	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/050557s025lbl.pdf

Therapeutic Equivalents for NDA 050557

BENZAMYCIN

GEL;TOPICAL; 5%;3%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BENZAMYCIN	BENZOYL PEROXIDE; ERYTHROMYCIN	5%;3%	GEL;TOPICAL	Prescription	Yes	AB	050557	VALEANT INTL
ERYTHROMYCIN AND BENZOYL PEROXIDE	BENZOYL PEROXIDE; ERYTHROMYCIN	5%;3%	GEL;TOPICAL	Prescription	No	AB	065385	LYNE