Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210215
Company: NOVELGENIX THERAPS
Company: NOVELGENIX THERAPS
| 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 |
|---|---|---|---|---|---|---|---|
| 03/10/2020 | ORIG-1 | Approval | STANDARD |
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 | 210215 | NOVELGENIX THERAPS |
| 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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