Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 217229
Company: SUN PHARM INDS INC

Products on ANDA 217229

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 217229

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/25/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/10/2024	SUPPL-1	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 217229

METHYLPHENIDATE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 72MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	076655	ACTAVIS LABS FL
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	205327	OSMOTICA PHARM US
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	72MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	217229	SUN PHARM INDS INC