Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204266
Company: AUROLIFE PHARMA LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 5MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 10MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 15MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 20MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 25MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 35MG CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
DEXMETHYLPHENIDATE HYDROCHLORIDE DEXMETHYLPHENIDATE HYDROCHLORIDE 40MG CAPSULE, 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
05/04/2021 ORIG-3 Approval

Label is not available on this site.

12/21/2015 ORIG-2 Approval

Label is not available on this site.

08/25/2015 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/29/2019 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

11/29/2019 SUPPL-3 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

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