Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 087501
Company: ROXANE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMINOPHYLLINE AMINOPHYLLINE 200MG TABLET;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
02/09/1982 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
08/15/1996 SUPPL-12 Labeling

Label is not available on this site.

08/28/1996 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

09/11/1995 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

09/04/1992 SUPPL-9 Labeling

Label is not available on this site.

10/03/1990 SUPPL-8 Labeling

Label is not available on this site.

08/26/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/26/1988 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

12/11/1984 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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