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 JUBILANT GENERICS
Abbreviated New Drug Application (ANDA): 210403
Company: JUBILANT GENERICS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/07/2018 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/25/2019 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
AMANTADINE HYDROCHLORIDE
TABLET;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 | TABLET;ORAL | Prescription | No | AB | 214284 | ALEMBIC PHARMS LTD |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 210403 | JUBILANT GENERICS |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 210215 | NOVELGENIX THERAPS |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 209035 | STRIDES PHARMA |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 076186 | UPSHER SMITH LABS |
| AMANTADINE HYDROCHLORIDE | AMANTADINE HYDROCHLORIDE | 100MG | TABLET;ORAL | Prescription | No | AB | 208096 | WATSON LABS INC |
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