Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086998
Company: SCHERING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THEO-DUR THEOPHYLLINE 200MG 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
01/31/1980 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-38 Labeling

Label is not available on this site.

08/18/1997 SUPPL-35 Labeling

Label is not available on this site.

08/18/1997 SUPPL-34 Labeling

Label is not available on this site.

07/17/1996 SUPPL-33 Labeling

Label is not available on this site.

06/22/1988 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

06/22/1988 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

10/26/1989 SUPPL-29 Labeling

Label is not available on this site.

12/18/1986 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

03/14/1986 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

03/14/1986 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

03/14/1986 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

02/18/1986 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

09/20/1985 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

01/03/1984 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

07/18/1983 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

01/12/1983 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/12/1983 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

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