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
CELONTIN از شرکت PARKE DAVIS
New Drug Application (NDA): 010596
Company: PARKE DAVIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CELONTIN | METHSUXIMIDE | 150MG | CAPSULE;ORAL | Discontinued |
None |
Yes | No |
| CELONTIN | METHSUXIMIDE | 300MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/08/1957 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
PRIORITY |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/15/2011 | SUPPL-23 | REMS-Modified |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/010596s023ltr.pdf |
|
| 10/11/2010 | SUPPL-22 | Labeling, REMS-Proposal |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010596s22lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/010596s022ltr.pdf |
||
| 04/23/2009 | SUPPL-21 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/010596s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/010596s021ltr.pdf |
||
| 04/17/2002 | SUPPL-17 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/10596s17ltr.pdf |
|
| 04/11/2000 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/1999 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/20/1997 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/09/2001 | SUPPL-12 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10596s9s12ltr.pdf |
|
| 12/11/1995 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/24/1990 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 04/09/2001 | SUPPL-9 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10596s9s12ltr.pdf |
|
| 08/20/1987 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/27/1981 | SUPPL-7 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/27/1981 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/23/1977 | SUPPL-4 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 10/11/2010 | SUPPL-22 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010596s22lbl.pdf | |
| 10/11/2010 | SUPPL-22 |
REMS-Proposal |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/010596s22lbl.pdf | |
| 04/23/2009 | SUPPL-21 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/010596s021lbl.pdf |
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