Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 204659
Company: PAR PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 36MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 54MG 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
07/15/2019 ORIG-1 Approval STANDARD

Label is not available on this site.

METHYLPHENIDATE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 36MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CONCERTA METHYLPHENIDATE HYDROCHLORIDE 36MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021121 JANSSEN PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 36MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076772 ACTAVIS LABS FL
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 36MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 210818 ALVOGEN PINE BROOK
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 36MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207515 AMNEAL PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 36MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211918 ANDOR PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 36MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 208607 ANI PHARMS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 36MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206726 MYLAN
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 36MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205327 OSMOTICA
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 36MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204659 PAR PHARM

TABLET, EXTENDED RELEASE;ORAL; 54MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CONCERTA METHYLPHENIDATE HYDROCHLORIDE 54MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021121 JANSSEN PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 54MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076655 ACTAVIS LABS FL
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 54MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 210818 ALVOGEN PINE BROOK
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 54MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207515 AMNEAL PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 54MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211918 ANDOR PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 54MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 208607 ANI PHARMS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 54MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206726 MYLAN
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 54MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205327 OSMOTICA
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 54MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204659 PAR PHARM

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