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
CECLOR از شرکت LILLY
New Drug Application (NDA): 050521
Company: LILLY
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CECLOR | CEFACLOR | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE;ORAL | Discontinued |
None |
Yes | No |
| CECLOR | CEFACLOR | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE;ORAL | Discontinued |
None |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 04/04/1979 | 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 |
|---|---|---|---|---|---|
| 03/17/2004 | SUPPL-27 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50521slr027,50522slr027_cefaclor_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50521slr027,50522slr027ltr.pdf |
||
| 03/03/2003 | SUPPL-26 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50521slr026,50522slr024ltr.pdf |
|
| 04/27/2000 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/13/2000 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/29/1999 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/18/1998 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 02/02/1998 | SUPPL-21 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/050521s021_ceclor.pdf |
|
| 09/30/1996 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 03/06/1996 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 04/13/1995 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 05/28/1993 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 11/08/1991 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/10/1994 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/08/1991 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/01/1996 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 05/01/1996 | SUPPL-10 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/17/2004 | SUPPL-27 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50521slr027,50522slr027_cefaclor_lbl.pdf |
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