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
CARISOPRODOL از شرکت HIKMA INTL PHARMS
Abbreviated New Drug Application (ANDA): 040124
Company: HIKMA INTL PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARISOPRODOL | CARISOPRODOL | 350MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 01/24/1996 | ORIG-1 | Approval |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/09/2015 | SUPPL-20 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 05/27/2011 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/02/2010 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 12/31/2007 | SUPPL-14 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/040124s014ltr.pdf |
|
| 06/12/2002 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/12/2002 | SUPPL-10 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 10/15/2001 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/04/2000 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 12/04/2000 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/04/2000 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/04/2000 | SUPPL-5 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 12/04/2000 | SUPPL-4 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 10/01/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/24/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/24/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
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