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
CONRAY 30 از شرکت LIEBEL-FLARSHEIM
New Drug Application (NDA): 016983
Company: LIEBEL-FLARSHEIM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CONRAY 30 | IOTHALAMATE MEGLUMINE | 30% | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 08/06/1971 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/05/2017 | SUPPL-37 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016983s037lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/013295ig1s070,016983Orig1s037ltr.pdf |
||
| 07/06/2015 | SUPPL-35 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/013295s068,016983s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/013295Orig1s068,016983Orig1s035ltr.pdf |
||
| 12/19/2013 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/10/2013 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/27/1999 | SUPPL-29 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/13/1995 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 08/28/1992 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/04/1992 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/30/1990 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/12/1989 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 12/01/1989 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/10/1989 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/08/1985 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/09/1985 | SUPPL-20 | Efficacy |
Label is not available on this site. |
||
| 11/07/1984 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 06/28/1989 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/04/1984 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/25/1984 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/16/1982 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 08/24/1981 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/16/1982 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 09/08/1976 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/05/1976 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 06/20/1977 | SUPPL-9 | Efficacy |
Label is not available on this site. |
||
| 05/05/1976 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/23/1976 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/23/1976 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/30/1975 | SUPPL-5 | 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 |
|---|---|---|---|---|---|
| 04/05/2017 | SUPPL-37 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/016983s037lbl.pdf | |
| 07/06/2015 | SUPPL-35 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/013295s068,016983s035lbl.pdf |
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