Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 209311
Company: IRONSHORE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
JORNAY PM METHYLPHENIDATE HYDROCHLORIDE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
JORNAY PM METHYLPHENIDATE HYDROCHLORIDE 40MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
JORNAY PM METHYLPHENIDATE HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
JORNAY PM METHYLPHENIDATE HYDROCHLORIDE 80MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
JORNAY PM METHYLPHENIDATE HYDROCHLORIDE 100MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes 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
08/08/2018 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209311s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209311Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/209311Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/16/2019 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209311s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209311Orig1s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/16/2019 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209311s003lbl.pdf
08/08/2018 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209311s000lbl.pdf

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