Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 090044
Company: ORCHID HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 5MG TABLET;ORAL Discontinued None No No
MEMANTINE HYDROCHLORIDE MEMANTINE HYDROCHLORIDE 10MG TABLET;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
03/12/2012 ORIG-1 Approval Letter (PDF)
Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/090044s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/090044Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/21/2021 SUPPL-2 Labeling-Package Insert, Labeling-Patient Package Insert

Label is not available on this site.

01/06/2016 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

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