Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087571
Company: RHODES PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
09/01/1982 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-42 Labeling-Package Insert

Label is not available on this site.

11/20/2003 SUPPL-33 Labeling

Label is not available on this site.

07/18/2002 SUPPL-32 Labeling

Label is not available on this site.

08/28/2000 SUPPL-31 Manufacturing (CMC)-Facility

Label is not available on this site.

08/28/2000 SUPPL-30 Manufacturing (CMC)-Facility

Label is not available on this site.

08/03/2000 SUPPL-29 Manufacturing (CMC)-Facility

Label is not available on this site.

08/03/2000 SUPPL-28 Manufacturing (CMC)-Facility

Label is not available on this site.

08/03/2000 SUPPL-27 Manufacturing (CMC)-Facility

Label is not available on this site.

08/03/2000 SUPPL-26 Manufacturing (CMC)-Facility

Label is not available on this site.

08/03/2000 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

08/03/2000 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/03/2000 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

04/16/1997 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

09/23/1997 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/31/1996 SUPPL-20 Labeling

Label is not available on this site.

06/14/1993 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/22/1993 SUPPL-12 Labeling

Label is not available on this site.

05/01/1990 SUPPL-11 Labeling

Label is not available on this site.

10/22/1987 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/10/1989 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/10/1989 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/10/1989 SUPPL-5 Labeling

Label is not available on this site.

10/22/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/28/1983 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

THEOPHYLLINE

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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