Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075629
Company: SPECGX LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
METHYLIN ER METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No No
METHYLIN ER METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET, EXTENDED RELEASE;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
05/09/2000 ORIG-1 Approval Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75629ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/75-629_Mythylphenidate%20Hydrochloride.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/28/2016 SUPPL-15 Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide

Label is not available on this site.

10/28/2016 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

03/20/2015 SUPPL-12 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

01/21/2014 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

12/19/2012 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

12/10/2010 SUPPL-7 Labeling

Label is not available on this site.

04/24/2003 SUPPL-1 Labeling

Label is not available on this site.

METHYLIN ER

TABLET, EXTENDED RELEASE;ORAL; 10MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHYLIN ER METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075629 SPECGX LLC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207488 ABHAI LLC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204772 CNTY LINE PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 210992 GRANULES

TABLET, EXTENDED RELEASE;ORAL; 20MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
METHYLIN ER METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 075629 SPECGX LLC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 207488 ABHAI LLC
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 212288 ALKEM LABS LTD
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204772 CNTY LINE PHARMS
METHYLPHENIDATE HYDROCHLORIDE METHYLPHENIDATE HYDROCHLORIDE 20MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 210992 GRANULES

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