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): 018333
Company: ALLERGAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CARAFATE | SUCRALFATE | 1GM | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 10/30/1981 | 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 |
|---|---|---|---|---|---|
| 03/04/2013 | SUPPL-34 | 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 |
||
| 04/26/2007 | SUPPL-32 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018333s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018333s032ltr.pdf |
||
| 11/29/1995 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/15/1995 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/14/1994 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 12/28/1992 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 02/12/1991 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 10/05/1990 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/11/1990 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 12/16/1988 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/05/1988 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/19/1988 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 07/02/1986 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 08/05/1987 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/24/1985 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/05/1987 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/11/1990 | SUPPL-9 | Efficacy-New Indication |
Label is not available on this site. |
||
| 05/14/1985 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 09/24/1984 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 04/22/1983 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 06/01/1983 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/09/1983 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/16/1982 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 03/09/1982 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/04/2013 | SUPPL-34 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018333s034,019183s016lbl.pdf | |
| 04/26/2007 | SUPPL-32 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018333s032lbl.pdf |
CARAFATE
TABLET;ORAL; 1GM
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CARAFATE | SUCRALFATE | 1GM | TABLET;ORAL | Prescription | Yes | AB | 018333 | ALLERGAN |
| SUCRALFATE | SUCRALFATE | 1GM | TABLET;ORAL | Prescription | No | AB | 074415 | NOSTRUM LABS INC |
| SUCRALFATE | SUCRALFATE | 1GM | TABLET;ORAL | Prescription | No | AB | 070848 | TEVA |
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