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
CHIBROXIN از شرکت MERCK
New Drug Application (NDA): 019757
Company: MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHIBROXIN | NORFLOXACIN | 0.3% | SOLUTION/DROPS;OPHTHALMIC | Discontinued |
None |
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 |
|---|---|---|---|---|---|---|---|
| 06/17/1991 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
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 |
|---|---|---|---|---|---|
| 02/05/2001 | SUPPL-10 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19757S10lbl.pdf |
||
| 10/08/1999 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 02/24/1998 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/27/1998 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/24/1995 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/22/1993 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 06/30/1993 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/11/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 04/27/1993 | SUPPL-2 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 12/11/1992 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/05/2001 | SUPPL-10 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19757S10lbl.pdf |
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