Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210319
Company: SETON PHARMS
Company: SETON PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 2MG/ML | SOLUTION;ORAL | Prescription | AA | 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 |
---|---|---|---|---|---|---|---|
08/31/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
MEMANTINE HYDROCHLORIDE
SOLUTION;ORAL; 2MG/ML
TE Code = AA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 2MG/ML | SOLUTION;ORAL | Prescription | No | AA | 209955 | APOTEX |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 2MG/ML | SOLUTION;ORAL | Prescription | No | AA | 204033 | CHARTWELL MOLECULAR |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 2MG/ML | SOLUTION;ORAL | Prescription | No | AA | 202790 | MACLEODS PHARMS LTD |
MEMANTINE HYDROCHLORIDE | MEMANTINE HYDROCHLORIDE | 2MG/ML | SOLUTION;ORAL | Prescription | No | AA | 210319 | SETON PHARMS |