Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089131
Company: SCHERING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THEO-DUR THEOPHYLLINE 450MG TABLET, EXTENDED RELEASE;ORAL Discontinued None 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
06/25/1986 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
01/10/2002 SUPPL-23 Labeling

Label is not available on this site.

08/18/1997 SUPPL-19 Labeling

Label is not available on this site.

08/18/1997 SUPPL-18 Labeling

Label is not available on this site.

07/17/1996 SUPPL-17 Labeling

Label is not available on this site.

11/21/1990 SUPPL-16 Labeling

Label is not available on this site.

11/21/1990 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

06/22/1988 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/22/1988 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

10/26/1989 SUPPL-11 Labeling

Label is not available on this site.

08/20/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/20/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

08/20/1987 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

08/20/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

08/20/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

08/20/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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