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 ZHEJIANG JINGXIN
Abbreviated New Drug Application (ANDA): 209946
Company: ZHEJIANG JINGXIN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | 625MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 07/15/2020 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
COLESEVELAM HYDROCHLORIDE
TABLET;ORAL; 625MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | 625MG | TABLET;ORAL | Prescription | No | AB | 209038 | ALKEM LABS LTD |
| COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | 625MG | TABLET;ORAL | Prescription | No | AB | 208670 | BIONPHARMA INC |
| COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | 625MG | TABLET;ORAL | Prescription | No | AB | 210889 | DR REDDYS |
| COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | 625MG | TABLET;ORAL | Prescription | No | AB | 203480 | GLENMARK PHARMS LTD |
| COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | 625MG | TABLET;ORAL | Prescription | No | AB | 091600 | IMPAX LABS INC |
| COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | 625MG | TABLET;ORAL | Prescription | No | AB | 212050 | INVENTIA |
| COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | 625MG | TABLET;ORAL | Prescription | No | AB | 201354 | LUPIN LTD |
| COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | 625MG | TABLET;ORAL | Prescription | No | AB | 209946 | ZHEJIANG JINGXIN |
| COLESEVELAM HYDROCHLORIDE | COLESEVELAM HYDROCHLORIDE | 625MG | TABLET;ORAL | Prescription | No | AB | 207765 | ZYDUS PHARMS |
| WELCHOL | COLESEVELAM HYDROCHLORIDE | 625MG | TABLET;ORAL | Prescription | Yes | AB | 021176 | DAIICHI SANKYO |
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