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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209211
Company: CEDIPROF INC

Products on ANDA 209211

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209211

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/19/2018	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
07/20/2023	SUPPL-2	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 209211

DEXMETHYLPHENIDATE HYDROCHLORIDE

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	206931	ABHAI INC
DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	212631	ALKEM LABS LTD
DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	209211	CEDIPROF INC
DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	204534	NOVEL LABS INC
DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	208756	RHODES PHARMS
DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	201231	SUN PHARM INDUSTRIES
DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	207901	TRIS PHARMA INC
FOCALIN	DEXMETHYLPHENIDATE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	Yes	AB	021278	SANDOZ

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	206931	ABHAI INC
DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	212631	ALKEM LABS LTD
DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	209211	CEDIPROF INC
DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	204534	NOVEL LABS INC
DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	208756	RHODES PHARMS
DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	201231	SUN PHARM INDUSTRIES
DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	No	AB	207901	TRIS PHARMA INC
FOCALIN	DEXMETHYLPHENIDATE HYDROCHLORIDE	10MG	TABLET;ORAL	Prescription	Yes	AB	021278	SANDOZ

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