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
BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE از شرکت PADAGIS US
Abbreviated New Drug Application (ANDA): 062166
Company: PADAGIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE | BACITRACIN ZINC; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE | 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM | OINTMENT;OPHTHALMIC | Prescription |
None |
No | 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 |
|---|---|---|---|---|---|---|---|
| 04/14/1981 | ORIG-1 | Approval |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/12/2001 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/07/1996 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/27/1995 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/27/1995 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/14/1995 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/14/1995 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/07/1993 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 12/09/1994 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/18/1992 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/17/1989 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/17/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
منبع : www.accessdata.fda.gov
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