Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202892
Company: OXFORD PHARMS

Products on ANDA 202892

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	AB	No	No
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	AB	No	No
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202892

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/23/2014	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 202892

METHYLPHENIDATE HYDROCHLORIDE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	206932	ABHAI INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	213936	ACCORD HLTHCARE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	211779	ALKEM LABS LTD
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	207416	ASCENT PHARMS INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	209753	BIONPHARMA
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	208737	CEDIPROF INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	091159	MOUNTAIN
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	207884	NOVEL LABS INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	202892	OXFORD PHARMS
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	212697	PRINSTON INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	040300	SPECGX LLC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	090710	SUN PHARM INDS INC
RITALIN	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	Yes	AB	010187	SANDOZ

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	206932	ABHAI INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	213936	ACCORD HLTHCARE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	211779	ALKEM LABS LTD
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	207416	ASCENT PHARMS INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	209753	BIONPHARMA
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	208737	CEDIPROF INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	091159	MOUNTAIN
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	207884	NOVEL LABS INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	202892	OXFORD PHARMS
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	212697	PRINSTON INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	040300	SPECGX LLC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	090710	SUN PHARM INDS INC
RITALIN	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	Yes	AB	010187	SANDOZ

TABLET;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	206932	ABHAI INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	213936	ACCORD HLTHCARE
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	211779	ALKEM LABS LTD
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	207416	ASCENT PHARMS INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	209753	BIONPHARMA
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	208737	CEDIPROF INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	091159	MOUNTAIN
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	207884	NOVEL LABS INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	202892	OXFORD PHARMS
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	212697	PRINSTON INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	040300	SPECGX LLC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	No	AB	090710	SUN PHARM INDS INC
RITALIN	METHYLPHENIDATE HYDROCHLORIDE	20MG	TABLET;ORAL	Prescription	Yes	AB	010187	SANDOZ