Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085003
Company: HIKMA INTL PHARMS
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
05/28/1976 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
07/03/2002 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

12/11/2000 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

12/11/2000 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

01/13/2000 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

10/01/1998 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

09/24/1996 SUPPL-37 Labeling

Label is not available on this site.

05/26/1995 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

06/16/1994 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

10/31/1990 SUPPL-34 Labeling

Label is not available on this site.

04/02/1991 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

11/22/1991 SUPPL-32 Labeling

Label is not available on this site.

04/02/1991 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

11/22/1991 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

11/22/1991 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

01/27/1989 SUPPL-26 Labeling

Label is not available on this site.

01/27/1989 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

07/20/1988 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

07/16/1986 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

07/16/1986 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

07/16/1986 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

03/11/1985 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

03/29/1984 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/17/1984 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

08/10/1983 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/01/1982 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

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