Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 074883
Company: IVAX SUB TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ETODOLAC ETODOLAC 400MG TABLET;ORAL Discontinued None No No
ETODOLAC ETODOLAC 500MG 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
02/28/1997 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
07/29/2002 SUPPL-21 Manufacturing (CMC)-Facility

Label is not available on this site.

03/12/2002 SUPPL-20 Manufacturing (CMC)-Facility

Label is not available on this site.

01/28/2000 SUPPL-18 Manufacturing (CMC)-Facility

Label is not available on this site.

10/22/1999 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

10/22/1999 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/22/1999 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

10/22/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

10/22/1999 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

07/21/1999 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

07/21/1999 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

07/21/1999 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/21/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

07/21/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

12/09/1998 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/20/1998 SUPPL-6 Labeling

Label is not available on this site.

11/20/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/20/1998 SUPPL-4 Manufacturing (CMC)-New Strength

Label is not available on this site.

01/20/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

02/25/1998 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/07/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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