Drugs@FDA: FDA-Approved Drugs

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

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

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
ERYTHROMYCIN AND BENZOYL PEROXIDE BENZOYL PEROXIDE; ERYTHROMYCIN 5%;3% GEL;TOPICAL Prescription No AB 065112 TOLMAR

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