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
CESAMET از شرکت BAUSCH
New Drug Application (NDA): 018677
Company: BAUSCH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CESAMET | NABILONE | 1MG | CAPSULE;ORAL | Prescription |
None |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/26/1985 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018677Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/30/2015 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/05/2008 | SUPPL-13 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018677s013ltr.pdf |
|
| 05/15/2006 | SUPPL-11 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018677s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018677s011LTR.pdf |
||
| 06/23/1989 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 04/11/1989 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 03/18/1988 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 11/30/1987 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 12/04/1986 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/04/1986 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 05/15/2006 | SUPPL-11 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018677s011lbl.pdf |
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