Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 091601
Company: TRIS PHARMA INC

Products on ANDA 091601

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 091601

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/23/2010	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/091601s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/13/2024	SUPPL-14	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/06/2022	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/06/2022	SUPPL-6	Labeling-Package Insert		Label is not available on this site.
09/06/2022	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
09/06/2022	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
09/19/2013	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 091601

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