Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204115
Company: NOVEL LABS INC
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 Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/25/2015 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/204115Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/04/2017 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

12/27/2016 SUPPL-2 Labeling-Package Insert

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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