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
CYSTADANE از شرکت ORPHAN EUROPE
New Drug Application (NDA): 020576
Company: ORPHAN EUROPE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYSTADANE | BETAINE | 1GM/SCOOPFUL | FOR SOLUTION;ORAL | Prescription |
None |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/25/1996 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
PRIORITY; Orphan |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020576Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/06/2018 | SUPPL-14 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020576s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020576Orig1s014ltr.pdf |
||
| 04/05/2010 | SUPPL-10 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020576s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020576s010ltr.pdf |
||
| 02/17/2006 | SUPPL-8 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020576s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020576s008ltr.pdf |
||
| 08/25/2000 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/21/2000 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/16/1999 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 08/13/1998 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/05/1998 | SUPPL-1 | Labeling |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/06/2018 | SUPPL-14 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020576s014lbl.pdf | |
| 04/05/2010 | SUPPL-10 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020576s010lbl.pdf | |
| 02/17/2006 | SUPPL-8 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020576s008lbl.pdf |
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