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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 208328
Company: AMNEAL 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;14MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE 10MG;28MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None 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
01/27/2017 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208328Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208328Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/09/2018 SUPPL-1 Labeling-Patient Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/27/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208328Orig1s000lbl.pdf
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