Drugs@FDA: FDA-Approved Drugs

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

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 204115 NOVEL LABS 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 204115 NOVEL LABS 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 204115 NOVEL LABS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, CHEWABLE;ORAL Prescription No AB 205756 RISING

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