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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205756
Company: RISING

Products on ANDA 205756

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE;ORAL	Prescription	AB	No	No
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE;ORAL	Prescription	AB	No	No
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 205756

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/07/2016	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
04/29/2026	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
10/13/2023	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
06/25/2021	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
06/22/2021	SUPPL-2	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 205756

METHYLPHENIDATE HYDROCHLORIDE

TABLET, CHEWABLE;ORAL; 2.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE;ORAL	Prescription	No	AB	210354	ASCENT PHARMS INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET, CHEWABLE;ORAL	Prescription	No	AB	205756	RISING

TABLET, CHEWABLE;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, CHEWABLE;ORAL	Prescription	No	AB	210354	ASCENT PHARMS INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET, CHEWABLE;ORAL	Prescription	No	AB	205756	RISING

TABLET, CHEWABLE;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, CHEWABLE;ORAL	Prescription	No	AB	210354	ASCENT PHARMS INC
METHYLPHENIDATE HYDROCHLORIDE	METHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET, CHEWABLE;ORAL	Prescription	No	AB	205756	RISING

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