Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205327
Company: OSMOTICA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 18MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 27MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 36MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 54MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 72MG TABLET, EXTENDED RELEASE;ORAL Prescription None 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
07/28/2017 ORIG-1 Approval STANDARD Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205327Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/205327Orig1s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/21/2018 SUPPL-7 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Proprietary Name Change

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
07/28/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/205327Orig1s000lbl.pdf

METHYLPHENIDATE HYDROCHLORIDE

TABLET, EXTENDED RELEASE;ORAL; 18MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CONCERTA METHYLPHENIDATE HYDROCHLORIDE 18MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021121 JANSSEN PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 18MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076772 ACTAVIS LABS FL
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 18MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 210818 ALVOGEN PINE BROOK
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 18MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207515 AMNEAL PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 18MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211918 ANDOR PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 18MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211009 ASCENT PHARMS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 18MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 213473 DR REDDYS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 18MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206726 MYLAN
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 18MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205327 OSMOTICA
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 18MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205135 SUN PHARM INDS INC

TABLET, EXTENDED RELEASE;ORAL; 27MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CONCERTA METHYLPHENIDATE HYDROCHLORIDE 27MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021121 JANSSEN PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 27MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076772 ACTAVIS LABS FL
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 27MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 210818 ALVOGEN PINE BROOK
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 27MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207515 AMNEAL PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 27MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211918 ANDOR PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 27MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211009 ASCENT PHARMS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 27MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 213473 DR REDDYS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 27MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206726 MYLAN
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 27MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205327 OSMOTICA
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 27MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205135 SUN PHARM INDS INC

TABLET, EXTENDED RELEASE;ORAL; 36MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CONCERTA METHYLPHENIDATE HYDROCHLORIDE 36MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021121 JANSSEN PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 36MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076772 ACTAVIS LABS FL
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 36MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 210818 ALVOGEN PINE BROOK
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 36MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207515 AMNEAL PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 36MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211918 ANDOR PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 36MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211009 ASCENT PHARMS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 36MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 213473 DR REDDYS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 36MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206726 MYLAN
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 36MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205327 OSMOTICA
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 36MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205135 SUN PHARM INDS INC

TABLET, EXTENDED RELEASE;ORAL; 54MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CONCERTA METHYLPHENIDATE HYDROCHLORIDE 54MG TABLET, EXTENDED RELEASE;ORAL Prescription Yes AB 021121 JANSSEN PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 54MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076655 ACTAVIS LABS FL
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 54MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 210818 ALVOGEN PINE BROOK
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 54MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207515 AMNEAL PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 54MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211918 ANDOR PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 54MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 211009 ASCENT PHARMS INC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 54MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 213473 DR REDDYS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 54MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 206726 MYLAN
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 54MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205327 OSMOTICA
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 54MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 205135 SUN PHARM INDS INC

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