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
CHEMET از شرکت RECORDATI RARE
New Drug Application (NDA): 019998
Company: RECORDATI RARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHEMET | SUCCIMER | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/30/1991 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
PRIORITY; Orphan |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/02/2018 | SUPPL-21 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019998s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019998Orig1s021ltr.pdf |
||
| 07/25/2016 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/24/2014 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/14/2010 | SUPPL-17 | Labeling-Container/Carton Labels |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019998s017ltr.pdf |
|
| 07/11/2007 | SUPPL-13 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019998s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019998s013ltr.pdf |
||
| 10/05/1999 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 12/07/1999 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/1999 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/10/1998 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/14/1997 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/29/1992 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 02/25/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 05/06/1992 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 05/11/1992 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/06/1991 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/02/2018 | SUPPL-21 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019998s021lbl.pdf | |
| 07/11/2007 | SUPPL-13 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019998s013lbl.pdf |
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