U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. Drugs@FDA

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 073580
Company: IMPAX LABS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EMVERM MEBENDAZOLE 100MG TABLET, CHEWABLE;ORAL Prescription None No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
01/04/1995 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
07/21/2015 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

11/20/2002 SUPPL-14 Manufacturing (CMC)-Facility

Label is not available on this site.

11/20/2002 SUPPL-13 Manufacturing (CMC)-Facility

Label is not available on this site.

10/31/2001 SUPPL-12 Manufacturing (CMC)-Facility

Label is not available on this site.

10/31/2001 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

10/31/2001 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

01/23/2002 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

02/26/2001 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

03/23/1999 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

01/25/1999 SUPPL-6 Labeling

Label is not available on this site.

06/11/1998 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/03/1998 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/03/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

05/31/1996 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/26/1995 SUPPL-1 Labeling

Label is not available on this site.

Back to Top