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 از شرکت PAR PHARM
Abbreviated New Drug Application (ANDA): 070346
Company: PAR PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMILORIDE HYDROCHLORIDE | AMILORIDE HYDROCHLORIDE | 5MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/22/1986 | 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 |
|---|---|---|---|---|---|
| 06/18/2004 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 09/16/2002 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 06/07/2001 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/26/1997 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/26/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/24/1989 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 05/19/1989 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 10/05/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/16/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
AMILORIDE HYDROCHLORIDE
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMILORIDE HYDROCHLORIDE | AMILORIDE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 204180 | ANDA REPOSITORY |
| AMILORIDE HYDROCHLORIDE | AMILORIDE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 070346 | PAR PHARM |
| AMILORIDE HYDROCHLORIDE | AMILORIDE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 079133 | SIGMAPHARM LABS LLC |
| MIDAMOR | AMILORIDE HYDROCHLORIDE | 5MG | TABLET;ORAL | Prescription | Yes | AB | 018200 | PADAGIS US |
منبع : www.accessdata.fda.gov
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