Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085261
Company: IDT AUSTRALIA LTD
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMINOPHYLLINE AMINOPHYLLINE 200MG TABLET;ORAL Discontinued None No No
AMINOPHYLLINE AMINOPHYLLINE 100MG 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
12/22/1976 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
01/06/1995 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

12/10/1990 SUPPL-56 Labeling

Label is not available on this site.

11/30/1989 SUPPL-55 Labeling

Label is not available on this site.

11/30/1989 SUPPL-54 Labeling

Label is not available on this site.

06/19/1987 SUPPL-53 Manufacturing (CMC)

Label is not available on this site.

06/19/1987 SUPPL-52 Manufacturing (CMC)

Label is not available on this site.

06/19/1987 SUPPL-51 Manufacturing (CMC)

Label is not available on this site.

06/19/1987 SUPPL-50 Manufacturing (CMC)

Label is not available on this site.

08/23/1984 SUPPL-46 Manufacturing (CMC)

Label is not available on this site.

08/23/1984 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

02/03/1984 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

11/02/1982 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

05/24/1982 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

12/21/1981 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

12/21/1981 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

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