Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040086
Company: RHODES PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THEOPHYLLINE THEOPHYLLINE 600MG 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
04/15/1996 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
10/14/2011 SUPPL-17 Labeling-Package Insert

Label is not available on this site.

11/20/2003 SUPPL-8 Labeling

Label is not available on this site.

12/19/2002 SUPPL-7 Labeling

Label is not available on this site.

08/28/2000 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

08/28/2000 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

08/02/2000 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

08/02/2000 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

08/02/2000 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

08/02/2000 SUPPL-1 Manufacturing (CMC)-Facility

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

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