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 از شرکت PADAGIS US
Abbreviated New Drug Application (ANDA): 061212
Company: PADAGIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BACITRACIN | BACITRACIN | 500 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 |
|---|---|---|---|---|---|---|---|
| 11/09/1971 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/061212Orig1s000.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/01/2013 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/31/2002 | SUPPL-10 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 03/07/1996 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/27/1995 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/1995 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/12/1995 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1995 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/17/1989 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
حتما بخوانید : BACITRACIN از شرکت QUAD PHARMS
منبع : www.accessdata.fda.gov
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