Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 083242
Company: AMARIN PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AMEN MEDROXYPROGESTERONE ACETATE 10MG 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
05/15/1974 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
07/08/1997 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

05/05/1997 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

09/29/1994 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

09/28/1994 SUPPL-38 Labeling

Label is not available on this site.

02/03/1994 SUPPL-37 Labeling

Label is not available on this site.

01/29/1993 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

06/25/1991 SUPPL-35 Labeling

Label is not available on this site.

03/28/1991 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

01/27/1992 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

04/19/1990 SUPPL-32 Labeling

Label is not available on this site.

02/10/1989 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

05/10/1989 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

11/23/1987 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

03/25/1986 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

03/25/1986 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

08/08/1986 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

12/16/1985 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/16/1985 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

12/16/1985 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

06/22/1984 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/22/1984 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

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