Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087943
Company: AUXILIUM PHARMS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THEO-24 THEOPHYLLINE 200MG CAPSULE, EXTENDED RELEASE;ORAL Prescription 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
08/22/1983 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
03/25/2005 SUPPL-17 Labeling

Label is not available on this site.

12/20/2001 SUPPL-15 Manufacturing (CMC)-Facility

Label is not available on this site.

10/20/1997 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/11/1996 SUPPL-13 Labeling

Label is not available on this site.

02/10/1995 SUPPL-11 Labeling

Label is not available on this site.

04/25/1989 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

01/21/1988 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

06/28/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

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