Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 205831
Company: RHODES PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
APTENSIO XR METHYLPHENIDATE HYDROCHLORIDE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
APTENSIO XR METHYLPHENIDATE HYDROCHLORIDE 15MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
APTENSIO XR METHYLPHENIDATE HYDROCHLORIDE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
APTENSIO XR METHYLPHENIDATE HYDROCHLORIDE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
APTENSIO XR METHYLPHENIDATE HYDROCHLORIDE 40MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
APTENSIO XR METHYLPHENIDATE HYDROCHLORIDE 50MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
APTENSIO XR METHYLPHENIDATE HYDROCHLORIDE 60MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None 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
04/17/2015 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205831s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205831Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205831Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/205831Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/04/2017 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205831s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205831Orig1s003ltr.pdf
09/15/2015 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/04/2017 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205831s003lbl.pdf
04/17/2015 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205831s000lbl.pdf

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