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 از شرکت LIEBEL-FLARSHEIM
New Drug Application (NDA): 013295
Company: LIEBEL-FLARSHEIM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CONRAY | IOTHALAMATE MEGLUMINE | 60% | INJECTABLE;INJECTION | Prescription |
None |
Yes | Yes |
| CONRAY 43 | IOTHALAMATE MEGLUMINE | 43% | 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 |
|---|---|---|---|---|---|---|---|
| 08/16/1962 | 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 |
|---|---|---|---|---|---|
| 04/05/2017 | SUPPL-70 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/013295s070lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/013295ig1s070,016983Orig1s037ltr.pdf |
||
| 06/22/2016 | SUPPL-69 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/06/2015 | SUPPL-68 | 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 |
||
| 02/03/2015 | SUPPL-67 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/2014 | SUPPL-66 | Labeling-Package Insert |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/013295Orig1s066ltr.pdf |
|
| 02/25/2014 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/19/2013 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/2013 | SUPPL-63 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/2013 | SUPPL-62 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/10/2013 | SUPPL-61 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/13/2003 | SUPPL-60 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/13295slr060ltr.pdf |
|
| 02/26/2001 | SUPPL-59 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/27/1999 | SUPPL-58 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/13/1995 | SUPPL-57 | Labeling |
Label is not available on this site. |
||
| 08/28/1992 | SUPPL-56 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/04/1992 | SUPPL-55 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/30/1990 | SUPPL-54 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/28/1989 | SUPPL-53 | Labeling |
Label is not available on this site. |
||
| 12/01/1989 | SUPPL-52 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/19/1988 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/10/1989 | SUPPL-50 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/18/1986 | SUPPL-49 | Labeling |
Label is not available on this site. |
||
| 04/08/1985 | SUPPL-48 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/09/1985 | SUPPL-47 | Efficacy |
Label is not available on this site. |
||
| 10/25/1984 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 09/12/1984 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 06/28/1989 | SUPPL-44 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/10/1989 | SUPPL-43 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/04/1984 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/25/1984 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/19/1984 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 10/20/1982 | SUPPL-39 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/22/1982 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 01/26/1983 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 02/25/1983 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 01/26/1983 | SUPPL-33 | Efficacy |
Label is not available on this site. |
||
| 12/07/1979 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 10/20/1982 | SUPPL-31 | Efficacy |
Label is not available on this site. |
||
| 10/20/1978 | SUPPL-30 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/29/1978 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/17/1978 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/17/1978 | SUPPL-27 | Efficacy |
Label is not available on this site. |
||
| 10/17/1978 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/17/1978 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 05/05/1976 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 05/06/1976 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/23/1976 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/23/1976 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/30/1975 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/22/1975 | SUPPL-13 | Labeling |
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-70 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/013295s070lbl.pdf | |
| 07/06/2015 | SUPPL-68 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/013295s068,016983s035lbl.pdf |
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