Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070945
Company: IVAX SUB TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXAZEPAM OXAZEPAM 30MG CAPSULE;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
08/03/1987 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
12/16/2016 SUPPL-35 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

03/03/2008 SUPPL-32 Labeling

Label is not available on this site.

07/29/2002 SUPPL-26 Manufacturing (CMC)-Facility

Label is not available on this site.

09/12/2001 SUPPL-25 Manufacturing (CMC)-Facility

Label is not available on this site.

03/05/2001 SUPPL-23 Manufacturing (CMC)-Facility

Label is not available on this site.

09/11/2000 SUPPL-22 Labeling

Label is not available on this site.

09/11/2000 SUPPL-21 Manufacturing (CMC)-Facility

Label is not available on this site.

09/11/2000 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/28/2000 SUPPL-19 Manufacturing (CMC)-Facility

Label is not available on this site.

02/11/1999 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

02/11/1999 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/13/1999 SUPPL-16 Labeling

Label is not available on this site.

02/11/1999 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/09/1998 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/25/1998 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

05/30/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

09/01/1994 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/26/1993 SUPPL-10 Labeling

Label is not available on this site.

07/02/1993 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

08/21/1992 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

06/10/1992 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

02/02/1989 SUPPL-6 Labeling

Label is not available on this site.

07/26/1988 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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