Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085328
Company: SCHERING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THEO-DUR THEOPHYLLINE 100MG TABLET, EXTENDED RELEASE;ORAL Discontinued None No No
THEO-DUR THEOPHYLLINE 300MG 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
04/12/1979 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-48 Labeling

Label is not available on this site.

01/05/2001 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

09/08/1998 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

08/18/1997 SUPPL-43 Labeling

Label is not available on this site.

08/18/1997 SUPPL-42 Labeling

Label is not available on this site.

07/17/1996 SUPPL-41 Labeling

Label is not available on this site.

06/22/1988 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

06/22/1988 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

10/26/1989 SUPPL-37 Labeling

Label is not available on this site.

12/18/1986 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

09/18/1986 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

09/18/1986 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

09/18/1986 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

07/16/1986 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

03/14/1986 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

03/14/1986 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

03/14/1986 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

02/14/1986 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

06/04/1985 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

02/20/1985 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

02/21/1985 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

01/03/1984 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

01/11/1983 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

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