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 ZINC AND POLYMYXIN B SULFATE از شرکت AKORN
Abbreviated New Drug Application (ANDA): 064028
Company: AKORN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BACITRACIN ZINC AND POLYMYXIN B SULFATE | BACITRACIN ZINC; POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT;OPHTHALMIC | Prescription |
AT |
No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 01/30/1995 | 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 |
|---|---|---|---|---|---|
| 03/10/2017 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/27/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
BACITRACIN ZINC AND POLYMYXIN B SULFATE
OINTMENT;OPHTHALMIC; 500 UNITS/GM;10,000 UNITS/GM
TE Code = AT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BACITRACIN ZINC AND POLYMYXIN B SULFATE | BACITRACIN ZINC; POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT;OPHTHALMIC | Prescription | No | AT | 064028 | AKORN |
| BACITRACIN ZINC AND POLYMYXIN B SULFATE | BACITRACIN ZINC; POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT;OPHTHALMIC | Prescription | No | AT | 064046 | BAUSCH AND LOMB |
| BACITRACIN ZINC AND POLYMYXIN B SULFATE | BACITRACIN ZINC; POLYMYXIN B SULFATE | 500 UNITS/GM;10,000 UNITS/GM | OINTMENT;OPHTHALMIC | Prescription | No | AT | 065022 | PADAGIS US |
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