Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210924
Company: ACTAVIS ELIZABETH
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLPHENIDATE METHYLPHENIDATE 8.6MG TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Discontinued None No No
METHYLPHENIDATE METHYLPHENIDATE 17.3MG TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL Discontinued None No No
METHYLPHENIDATE METHYLPHENIDATE 25.9MG TABLET, ORALLY DISINTEGRATING, 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
06/19/2020 ORIG-1 Approval STANDARD Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210924Orig1s000ltr.pdf

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