Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 207587
Company: BRECKENRIDGE PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription AB No No
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription AB No No
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;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
03/03/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

METHYLPHENIDATE HYDROCHLORIDE

TABLET;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;ORAL Prescription No AB 206932 ABHAI INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 040220 ACTAVIS LABS FL INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 207416 ASCENT PHARMS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 209753 BIONPHARMA INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 207587 BRECKENRIDGE PHARM
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 208737 CEDIPROF INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 206840 CNTY LINE PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 091159 MOUNTAIN
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 207884 NOVEL LABS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 202892 OXFORD PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 040300 SPECGX LLC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription No AB 090710 SUN PHARM INDS INC
RITALIN METHYLPHENIDATE HYDROCHLORIDE 5MG TABLET;ORAL Prescription Yes AB 010187 NOVARTIS

TABLET;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;ORAL Prescription No AB 206932 ABHAI INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 040220 ACTAVIS LABS FL INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 207416 ASCENT PHARMS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 209753 BIONPHARMA INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 207587 BRECKENRIDGE PHARM
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 208737 CEDIPROF INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 206840 CNTY LINE PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 091159 MOUNTAIN
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 207884 NOVEL LABS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 202892 OXFORD PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 040300 SPECGX LLC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription No AB 090710 SUN PHARM INDS INC
RITALIN METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET;ORAL Prescription Yes AB 010187 NOVARTIS

TABLET;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 206932 ABHAI INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 040220 ACTAVIS LABS FL INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 207416 ASCENT PHARMS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 209753 BIONPHARMA INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 207587 BRECKENRIDGE PHARM
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 208737 CEDIPROF INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 206840 CNTY LINE PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 091159 MOUNTAIN
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 207884 NOVEL LABS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 202892 OXFORD PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 040300 SPECGX LLC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription No AB 090710 SUN PHARM INDS INC
RITALIN METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET;ORAL Prescription Yes AB 010187 NOVARTIS

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