اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
BENZAMYCIN از شرکت VALEANT INTL
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 |
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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