Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 206032
Company: MYLAN
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 Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206032Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/15/2020 SUPPL-4 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

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

Label is not available on this site.

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