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
CINOBAC از شرکت LILLY
New Drug Application (NDA): 018067
Company: LILLY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CINOBAC | CINOXACIN | 250MG | CAPSULE;ORAL | Discontinued |
None |
No | No |
| CINOBAC | CINOXACIN | 500MG | CAPSULE;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 06/13/1980 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
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 |
|---|---|---|---|---|---|
| 08/24/2000 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/21/2000 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/01/2002 | SUPPL-29 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18067s29lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18067slr029ltr.pdf |
||
| 08/04/1998 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/04/1998 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/13/1998 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/21/1996 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/07/1996 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/11/1992 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 08/11/1992 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 08/21/1989 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 12/02/1988 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 06/18/1987 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/18/1987 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/1987 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 11/25/1988 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/28/1987 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 11/22/1985 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 10/16/1985 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 05/31/1984 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/13/1987 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 11/03/1981 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/13/1981 | SUPPL-2 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/14/1980 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/01/2002 | SUPPL-29 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/18067s29lbl.pdf |
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