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
CYSTO-CONRAY از شرکت LIEBEL-FLARSHEIM
New Drug Application (NDA): 017057
Company: LIEBEL-FLARSHEIM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYSTO-CONRAY | IOTHALAMATE MEGLUMINE | 43% | Solution; Intravesical, Ureteral | Prescription |
None |
No | No |
| CYSTO-CONRAY II | IOTHALAMATE MEGLUMINE | 17.2% | SOLUTION;INTRAVESICAL | Prescription |
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 |
|---|---|---|---|---|---|---|---|
| 04/17/1972 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
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 |
|---|---|---|---|---|---|
| 12/19/2013 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/2013 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/10/2013 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/13/2002 | SUPPL-27 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17057slr027ltr.pdf |
|
| 10/27/1999 | SUPPL-26 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/13/1995 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 08/28/1992 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/04/1992 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/30/1990 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/01/1989 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/08/1987 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/28/1989 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/10/1989 | 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. |
||
| 06/26/1984 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/1983 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 09/06/1978 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/14/1976 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/14/1976 | 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. |
||
| 05/05/1976 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/23/1976 | 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. |
||
| 07/30/1975 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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