Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202608
Company: SPECGX LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 27MG TABLET, EXTENDED RELEASE;ORAL Prescription BX No No
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 36MG TABLET, EXTENDED RELEASE;ORAL Prescription BX No No
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 54MG TABLET, EXTENDED RELEASE;ORAL Prescription BX 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
12/28/2012 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202608Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/202608Orig1s000Approv.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/28/2016 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

10/28/2016 SUPPL-6 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

10/28/2016 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

METHYLPHENIDATE HYDROCHLORIDE

There are no Therapeutic Equivalents.

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