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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076772
Company: ACTAVIS LABS FL

Products on ANDA 076772

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	54MG	TABLET, EXTENDED RELEASE;ORAL	None (Tentative Approval)	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 076772

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/22/2018	ORIG-1	Approval				Label is not available on this site.

Therapeutic Equivalents for ANDA 076772

METHYLPHENIDATE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 18MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CONCERTA	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	021121	JANSSEN PHARMS
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	076772	ACTAVIS LABS FL
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214447	ALKEM LABS LTD
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211918	ANDOR PHARMS
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211009	ASCENT PHARMS INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	206726	AUROLIFE PHARMA LLC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213473	DR REDDYS
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205327	OSMOTICA PHARM US
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	18MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205135	SUN PHARM INDS INC

TABLET, EXTENDED RELEASE;ORAL; 27MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CONCERTA	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	021121	JANSSEN PHARMS
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	076772	ACTAVIS LABS FL
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	214447	ALKEM LABS LTD
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211918	ANDOR PHARMS
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	211009	ASCENT PHARMS INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	206726	AUROLIFE PHARMA LLC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213473	DR REDDYS
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205327	OSMOTICA PHARM US
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	27MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205135	SUN PHARM INDS INC

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	214447	ALKEM LABS LTD
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	211009	ASCENT PHARMS INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	206726	AUROLIFE PHARMA LLC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	213473	DR REDDYS
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205327	OSMOTICA PHARM US
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	36MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205135	SUN PHARM INDS INC

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