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
ACIPHEX SPRINKLE از شرکت AYTU
New Drug Application (NDA): 204736
Company: AYTU
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACIPHEX SPRINKLE | RABEPRAZOLE SODIUM | 5MG | CAPSULE, DELAYED RELEASE;ORAL | Discontinued |
None |
Yes | No |
| ACIPHEX SPRINKLE | RABEPRAZOLE SODIUM | 10MG | CAPSULE, DELAYED RELEASE;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 03/26/2013 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
PRIORITY |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204736s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/27/2020 | SUPPL-12 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204736s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/204736Orig1s012ltr.pdf |
||
| 06/07/2018 | SUPPL-10 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204736s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/204736Orig1s010ltr.pdf |
||
| 07/27/2017 | SUPPL-8 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204736s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204736Orig1s008ltr.pdf |
||
| 10/24/2016 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204736Orig1s007ltr.pdf |
|
| 10/13/2015 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/19/2014 | SUPPL-5 | Labeling-Package Insert, Labeling-Medication Guide |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020973s035204736s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020973Orig1s035,204736Orig1s005ltr.pdf |
||
| 10/15/2014 | SUPPL-4 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020973s034,204736s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204736Orig1s004,020973Orig1s034ltr.pdf |
||
| 04/04/2016 | SUPPL-3 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204736s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020973Orig1s033,204736Orig1s003ltr.pdf |
||
| 08/28/2013 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/27/2020 | SUPPL-12 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204736s012lbl.pdf | |
| 06/07/2018 | SUPPL-10 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/204736s010lbl.pdf | |
| 07/27/2017 | SUPPL-8 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204736s008lbl.pdf | |
| 04/04/2016 | SUPPL-3 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204736s003lbl.pdf | |
| 12/19/2014 | SUPPL-5 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020973s035204736s005lbl.pdf | |
| 12/19/2014 | SUPPL-5 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020973s035204736s005lbl.pdf | |
| 10/15/2014 | SUPPL-4 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020973s034,204736s004lbl.pdf | |
| 03/26/2013 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204736s000lbl.pdf |
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