Drugs@FDA: FDA-Approved Drugs
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. |
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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. |
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03/21/2002 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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04/17/2001 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/06/2001 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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09/27/2000 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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06/11/1997 | SUPPL-19 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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03/05/1996 | SUPPL-18 | Labeling |
Label is not available on this site. |
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06/08/1995 | SUPPL-17 | Labeling |
Label is not available on this site. |
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10/21/1994 | SUPPL-15 | Labeling |
Label is not available on this site. |
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04/07/1993 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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04/13/1993 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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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 | RISING |