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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 216117
Company: OSMOTICA PHARM US
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
RELEXXII METHYLPHENIDATE HYDROCHLORIDE 18MG TABLET, EXTENDED RELEASE;ORAL Prescription TBD Yes No
RELEXXII METHYLPHENIDATE HYDROCHLORIDE 27MG TABLET, EXTENDED RELEASE;ORAL Prescription TBD Yes No
RELEXXII METHYLPHENIDATE HYDROCHLORIDE 36MG TABLET, EXTENDED RELEASE;ORAL Prescription TBD Yes No
RELEXXII METHYLPHENIDATE HYDROCHLORIDE 45MG TABLET, EXTENDED RELEASE;ORAL Prescription TBD Yes No
RELEXXII METHYLPHENIDATE HYDROCHLORIDE 54MG TABLET, EXTENDED RELEASE;ORAL Prescription TBD Yes No
RELEXXII METHYLPHENIDATE HYDROCHLORIDE 63MG TABLET, EXTENDED RELEASE;ORAL Prescription TBD Yes No
RELEXXII METHYLPHENIDATE HYDROCHLORIDE 72MG TABLET, EXTENDED RELEASE;ORAL Prescription TBD Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/23/2022 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216117s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/216117Orig1s000ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/23/2022 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216117s000lbl.pdf

RELEXXII

There are no Therapeutic Equivalents.

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