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
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE از شرکت MYLAN
Abbreviated New Drug Application (ANDA): 075768
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET;ORAL | Prescription |
AB |
No | No |
| BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET;ORAL | Prescription |
AB |
No | No |
| BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 10MG;6.25MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/25/2000 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75768ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/02/2015 | SUPPL-16 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/24/2003 | SUPPL-1 | Labeling |
Label is not available on this site. |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
TABLET;ORAL; 2.5MG;6.25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 212678 | EDENBRIDGE PHARMS |
| BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 075768 | MYLAN |
| BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 075579 | SANDOZ |
| BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 079106 | UNICHEM |
| ZIAC | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 2.5MG;6.25MG | TABLET;ORAL | Prescription | Yes | AB | 020186 | TEVA BRANDED PHARM |
TABLET;ORAL; 5MG;6.25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 212678 | EDENBRIDGE PHARMS |
| BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 075768 | MYLAN |
| BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 075579 | SANDOZ |
| BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 079106 | UNICHEM |
| ZIAC | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 5MG;6.25MG | TABLET;ORAL | Prescription | Yes | AB | 020186 | TEVA BRANDED PHARM |
TABLET;ORAL; 10MG;6.25MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 10MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 212678 | EDENBRIDGE PHARMS |
| BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 10MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 075768 | MYLAN |
| BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 10MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 075579 | SANDOZ |
| BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 10MG;6.25MG | TABLET;ORAL | Prescription | No | AB | 079106 | UNICHEM |
| ZIAC | BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE | 10MG;6.25MG | TABLET;ORAL | Prescription | Yes | AB | 020186 | TEVA BRANDED PHARM |
منبع : www.accessdata.fda.gov
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