Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 208756
Company: RHODES PHARMS
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
11/20/2017 ORIG-1 Approval STANDARD

Label is not available on this site.

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 209468 LANNETT CO INC
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 208756 RHODES PHARMS
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 NOVARTIS

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 209468 LANNETT CO 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 208756 RHODES PHARMS
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 NOVARTIS

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 209468 LANNETT CO 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 208756 RHODES PHARMS
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 NOVARTIS

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