Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 212288
Company: ALKEM LABS LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET, EXTENDED RELEASE;ORAL Prescription AB 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
10/06/2020 ORIG-1 Approval STANDARD

Label is not available on this site.

METHYLPHENIDATE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHYLIN ER METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075629 SPECGX LLC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207488 ABHAI LLC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 212288 ALKEM LABS LTD
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204772 CNTY LINE PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 210992 GRANULES

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