Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 201231
Company: SUN PHARM INDUSTRIES

Products on ANDA 201231

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET;ORAL	Prescription	AB	No	No
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 201231

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/24/2015	ORIG-1	Approval	Not Applicable		Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/201231Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/27/2024	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/24/2023	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/24/2023	SUPPL-11	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
11/29/2019	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
11/29/2019	SUPPL-3	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.

Therapeutic Equivalents for ANDA 201231

DEXMETHYLPHENIDATE HYDROCHLORIDE

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET;ORAL	Prescription	No	AB	206931	ABHAI INC
DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET;ORAL	Prescription	No	AB	212631	ALKEM LABS LTD
DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET;ORAL	Prescription	No	AB	204534	NOVEL LABS INC
DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET;ORAL	Prescription	No	AB	201231	SUN PHARM INDUSTRIES
DEXMETHYLPHENIDATE HYDROCHLORIDE	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET;ORAL	Prescription	No	AB	207901	TRIS PHARMA INC
FOCALIN	DEXMETHYLPHENIDATE HYDROCHLORIDE	2.5MG	TABLET;ORAL	Prescription	Yes	AB	021278	SANDOZ

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	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	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