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 BAUSCH AND LOMB
Abbreviated New Drug Application (ANDA): 064046
Company: BAUSCH AND LOMB
| 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 | 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 |
|---|---|---|---|---|---|---|---|
| 01/26/1995 | 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 |
|---|---|---|---|---|---|
| 08/05/2002 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/27/2001 | SUPPL-10 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 03/07/2001 | SUPPL-9 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 06/27/2000 | SUPPL-8 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 04/28/2000 | SUPPL-7 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 06/07/1999 | SUPPL-6 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 05/26/1999 | SUPPL-5 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 10/22/1998 | SUPPL-4 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
| 05/04/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/20/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1996 | 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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