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
ALFUZOSIN HYDROCHLORIDE از شرکت APOTEX INC
Abbreviated New Drug Application (ANDA): 079013
Company: APOTEX INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALFUZOSIN HYDROCHLORIDE | ALFUZOSIN HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 07/18/2011 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/079013s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/07/2018 | SUPPL-6 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 01/15/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/15/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
ALFUZOSIN HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALFUZOSIN HYDROCHLORIDE | ALFUZOSIN HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 079013 | APOTEX INC |
| ALFUZOSIN HYDROCHLORIDE | ALFUZOSIN HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 079060 | AUROBINDO PHARMA LTD |
| ALFUZOSIN HYDROCHLORIDE | ALFUZOSIN HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 090284 | INVAGEN PHARMS |
| ALFUZOSIN HYDROCHLORIDE | ALFUZOSIN HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 079057 | SUN PHARM |
| ALFUZOSIN HYDROCHLORIDE | ALFUZOSIN HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203192 | UNICHEM |
| UROXATRAL | ALFUZOSIN HYDROCHLORIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 021287 | CONCORDIA |
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