Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211647
Company: ALKEM LABS LTD

Products on ANDA 211647

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211647

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/30/2020	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 211647

METHYLPHENIDATE HYDROCHLORIDE

SOLUTION;ORAL; 5MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHYLIN	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	Yes	AA	021419	SPECGX LLC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	207485	ABHAI LLC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	211647	ALKEM LABS LTD
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	207417	ASCENT PHARMS INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	204602	NOVEL LABS INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	210764	PATRIN
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	213567	QUAGEN
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	091601	TRIS PHARMA INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	210139	WES PHARMA INC

SOLUTION;ORAL; 10MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHYLIN	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION;ORAL	Prescription	Yes	AA	021419	SPECGX LLC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION;ORAL	Prescription	No	AA	207485	ABHAI LLC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION;ORAL	Prescription	No	AA	211647	ALKEM LABS LTD
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION;ORAL	Prescription	No	AA	207417	ASCENT PHARMS INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION;ORAL	Prescription	No	AA	204602	NOVEL LABS INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION;ORAL	Prescription	No	AA	210764	PATRIN
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION;ORAL	Prescription	No	AA	213567	QUAGEN
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION;ORAL	Prescription	No	AA	091601	TRIS PHARMA INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG/5ML	SOLUTION;ORAL	Prescription	No	AA	210139	WES PHARMA INC