Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208237
Company: ANI PHARMS
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | 10MG;21MG | CAPSULE, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
12/15/2023 | ORIG-2 | Tentative Approval | STANDARD |
Label is not available on this site. |
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12/15/2023 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/208237Orig1s000ltr.pdf |
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL; 10MG;21MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | 10MG;21MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | No | AB | 208237 | ANI PHARMS |
NAMZARIC | DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE | 10MG;21MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 206439 | ABBVIE |