Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205905
Company: SUN PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 7MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 14MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 21MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 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
09/28/2016 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205905Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/205905Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/15/2020 SUPPL-3 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

03/15/2020 SUPPL-1 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/28/2016 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/205905Orig1s000lbl.pdf

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