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
CAFERGOT از شرکت NOVARTIS
New Drug Application (NDA): 009000
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CAFERGOT | CAFFEINE; ERGOTAMINE TARTRATE | 100MG;2MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | SUPPOSITORY;RECTAL | Discontinued |
None |
Yes | 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 |
|---|---|---|---|---|---|---|---|
| 04/24/1953 | ORIG-1 | Approval |
Type 4 – New Combination |
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 |
|---|---|---|---|---|---|
| 11/07/2001 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/02/2001 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/29/2001 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/04/2002 | SUPPL-23 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/9000s22s23lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/9000s022ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/09000_S022&S023_Cafergot_APPROVAL PACKAGE.pdf |
||
| 06/04/2002 | SUPPL-22 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/9000s22s23lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/9000s022ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/09000_S022&S023_Cafergot_APPROVAL PACKAGE.pdf |
||
| 10/31/2000 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 10/31/2000 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 07/14/1993 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/31/2000 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 04/15/1993 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/31/2000 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 03/04/1994 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/31/2000 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 11/17/1988 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/10/1989 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/15/1988 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/25/1986 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/16/1985 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/15/1981 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/29/1981 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/06/1979 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/19/1979 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/04/2002 | SUPPL-23 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/9000s22s23lbl.pdf | |
| 06/04/2002 | SUPPL-22 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/9000s22s23lbl.pdf |
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