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
CETROTIDE از شرکت EMD SERONO INC
New Drug Application (NDA): 021197
Company: EMD SERONO INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CETROTIDE | CETRORELIX | EQ 0.25MG BASE/ML | INJECTABLE;INJECTION | Prescription |
None |
Yes | Yes |
| CETROTIDE | CETRORELIX | EQ 3MG BASE/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 08/11/2000 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21197lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/22/2017 | SUPPL-18 | Labeling-Container/Carton Labels |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021197Orig1s018ltr.pdf |
|
| 03/13/2013 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/15/2013 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/29/2013 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/04/2008 | SUPPL-10 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021197s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021197s010ltr.pdf |
||
| 04/30/2004 | SUPPL-5 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21197slr003,004,005ltr.pdf |
|
| 04/30/2004 | SUPPL-4 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21197slr003,004,005ltr.pdf |
|
| 04/30/2004 | SUPPL-3 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21197slr003,004,005ltr.pdf |
|
| 12/13/2000 | SUPPL-2 | 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 |
|---|---|---|---|---|---|
| 04/04/2008 | SUPPL-10 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021197s010lbl.pdf | |
| 08/11/2000 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21197lbl.pdf |
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