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
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE از شرکت MYLAN
Abbreviated New Drug Application (ANDA): 073209
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | EQ 5MG ANHYDROUS;50MG | TABLET;ORAL | Prescription |
AB |
No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/31/1991 | ORIG-1 | Approval |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/20/2020 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/19/2012 | SUPPL-22 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/14/2003 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 09/18/2002 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 08/28/2000 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/01/2000 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/05/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/15/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/18/1993 | SUPPL-1 | Labeling |
Label is not available on this site. |
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
TABLET;ORAL; EQ 5MG ANHYDROUS;50MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | EQ 5MG ANHYDROUS;50MG | TABLET;ORAL | Prescription | No | AB | 071111 | BARR |
| AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE | EQ 5MG ANHYDROUS;50MG | TABLET;ORAL | Prescription | No | AB | 073209 | MYLAN |
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