Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040560
Company: MYLAN IRELAND LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THEOPHYLLINE THEOPHYLLINE 600MG TABLET, EXTENDED RELEASE; ORAL Prescription None No No
THEOPHYLLINE THEOPHYLLINE 600MG TABLET, EXTENDED RELEASE;ORAL Prescription AB No Yes
THEOPHYLLINE THEOPHYLLINE 400MG 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
04/21/2006 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/20/2015 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

THEOPHYLLINE

TABLET, EXTENDED RELEASE;ORAL; 600MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
THEOPHYLLINE THEOPHYLLINE 600MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090355 GLENMARK GENERICS
THEOPHYLLINE THEOPHYLLINE 600MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 040560 MYLAN IRELAND LTD
THEOPHYLLINE THEOPHYLLINE 600MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 040086 RHODES PHARMS

TABLET, EXTENDED RELEASE;ORAL; 400MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
THEOPHYLLINE THEOPHYLLINE 400MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 090355 GLENMARK GENERICS
THEOPHYLLINE THEOPHYLLINE 400MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 040560 MYLAN IRELAND LTD
THEOPHYLLINE THEOPHYLLINE 400MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 087571 RHODES PHARMS

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