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 AKORN
Abbreviated New Drug Application (ANDA): 074170
Company: AKORN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 50MG/5ML | SYRUP;ORAL | Prescription |
AA |
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 |
|---|---|---|---|---|---|---|---|
| 10/28/1994 | 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 |
|---|---|---|---|---|---|
| 06/04/2014 | SUPPL-3 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 06/17/2011 | SUPPL-2 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2009 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
AMANTADINE HYDROCHLORIDE
SYRUP;ORAL; 50MG/5ML
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 50MG/5ML | SYRUP;ORAL | Prescription | No | AA | 074170 | AKORN |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 50MG/5ML | SYRUP;ORAL | Prescription | No | AA | 074028 | ANDA REPOSITORY |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 50MG/5ML | SYRUP;ORAL | Prescription | No | AA | 075819 | CMP PHARMA INC |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 50MG/5ML | SYRUP;ORAL | Prescription | No | AA | 074509 | PHARM ASSOC |
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