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
CARAFATE از شرکت ALLERGAN
New Drug Application (NDA): 019183
Company: ALLERGAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARAFATE | SUCRALFATE | 1GM/10ML | SUSPENSION;ORAL | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 12/16/1993 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019183_biopharm.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/15/2017 | SUPPL-19 | Labeling-Container/Carton Labels, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019183s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019183Orig1s019ltr.pdf |
||
| 06/06/2016 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/2013 | SUPPL-16 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018333s034,019183s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018333Orig1s034,019183Orig1s016ltr.pdf |
||
| 12/21/2010 | SUPPL-14 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019183s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019183s014ltr.pdf |
||
| 04/26/2007 | SUPPL-11 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019183s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019183s011ltr.pdf |
||
| 02/10/2006 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019183s009ltr.pdf |
|
| 02/08/2000 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/16/1997 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/14/1997 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/21/1995 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/13/1994 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 04/11/1994 | SUPPL-1 | 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 |
|---|---|---|---|---|---|
| 08/15/2017 | SUPPL-19 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019183s019lbl.pdf | |
| 08/15/2017 | SUPPL-19 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019183s019lbl.pdf | |
| 03/04/2013 | SUPPL-16 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018333s034,019183s016lbl.pdf | |
| 12/21/2010 | SUPPL-14 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019183s014lbl.pdf | |
| 04/26/2007 | SUPPL-11 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019183s011lbl.pdf |
CARAFATE
SUSPENSION;ORAL; 1GM/10ML
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARAFATE | SUCRALFATE | 1GM/10ML | SUSPENSION;ORAL | Prescription | Yes | AB | 019183 | ALLERGAN |
| SUCRALFATE | SUCRALFATE | 1GM/10ML | SUSPENSION;ORAL | Prescription | No | AB | 209356 | AMNEAL |
نظرات کاربران