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
AMANTADINE HYDROCHLORIDE از شرکت BIONPHARMA INC
Abbreviated New Drug Application (ANDA): 078720
Company: BIONPHARMA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 05/29/2008 | 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 |
|---|---|---|---|---|---|
| 10/30/2017 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/01/2011 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/25/2009 | SUPPL-1 | Labeling |
Label is not available on this site. |
AMANTADINE HYDROCHLORIDE
CAPSULE;ORAL; 100MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 208966 | ALEMBIC PHARMS LTD |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 078720 | BIONPHARMA INC |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 209171 | HERITAGE PHARMA |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 210129 | NOVELGENIX THERAPS |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 212044 | RUBICON |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 071293 | SANDOZ |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 209047 | STRIDES PHARMA |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 070589 | UPSHER SMITH LABS |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 208107 | WATSON LABS INC |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | CAPSULE;ORAL | Prescription | No | AB | 208278 | ZYDUS PHARMS |
حتما بخوانید : AMANTADINE HYDROCHLORIDE از شرکت PHARM ASSOC
منبع : www.accessdata.fda.gov
نظرات کاربران