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
COLESEVELAM HYDROCHLORIDE از شرکت GLENMARK PHARMS LTD
Abbreviated New Drug Application (ANDA): 202190
Company: GLENMARK PHARMS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | 1.875GM/PACKET | FOR SUSPENSION;ORAL | Prescription |
None |
No | No |
| COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | 3.75GM/PACKET | FOR SUSPENSION;ORAL | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 07/16/2018 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202190Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/31/2021 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/16/2020 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/16/2020 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
COLESEVELAM HYDROCHLORIDE
FOR SUSPENSION;ORAL; 3.75GM/PACKET
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | 3.75GM/PACKET | FOR SUSPENSION;ORAL | Prescription | No | AB | 210316 | ALKEM LABS LTD |
| COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | 3.75GM/PACKET | FOR SUSPENSION;ORAL | Prescription | No | AB | 202190 | GLENMARK PHARMS LTD |
| WELCHOL | COLESEVELAM HYDROCHLORIDE | 3.75GM/PACKET | FOR SUSPENSION;ORAL | Prescription | Yes | AB | 022362 | DAIICHI SANKYO |
منبع : www.accessdata.fda.gov
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