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
CEPHALEXIN از شرکت SUN PHARM INDS LTD
Abbreviated New Drug Application (ANDA): 065007
Company: SUN PHARM INDS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE | CAPSULE;ORAL | Discontinued |
None |
No | No |
| CEPHALEXIN | CEPHALEXIN | EQ 500MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 09/16/1999 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/65007ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/02/2004 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 11/03/2003 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 11/03/2003 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 09/05/2001 | SUPPL-6 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/05/2001 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 06/29/2000 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/18/2000 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/18/2000 | SUPPL-2 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 03/01/2000 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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