Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084540
Company: HIKMA INTL PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
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
11/26/1975 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
07/18/2002 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

01/25/2001 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

01/25/2001 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

01/13/2000 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1998 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

09/24/1996 SUPPL-35 Labeling

Label is not available on this site.

05/26/1995 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

06/16/1994 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

06/19/1991 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

04/18/1991 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

09/25/1990 SUPPL-27 Labeling

Label is not available on this site.

01/27/1989 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

04/29/1988 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

04/29/1988 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/29/1988 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

02/11/1988 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

03/11/1985 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

03/29/1984 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/04/1984 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/29/1982 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

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