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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088639
Company: BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 50MG 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
07/02/1984 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
04/16/2024 SUPPL-48 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/18/2023 SUPPL-47 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/18/2023 SUPPL-46 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/13/2023 SUPPL-45 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/13/2023 SUPPL-41 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/18/2018 SUPPL-40 REMS - PROPOSAL - D-N-A

Label is not available on this site.

12/13/2023 SUPPL-38 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/29/2015 SUPPL-34 Labeling-Package Insert

Label is not available on this site.

05/29/2015 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

05/29/2015 SUPPL-32 Labeling-Container/Carton Labels

Label is not available on this site.

09/02/2009 SUPPL-31 Labeling-Package Insert

Label is not available on this site.

03/02/2004 SUPPL-27 Labeling

Label is not available on this site.

07/27/2001 SUPPL-26 Manufacturing (CMC)-Manufacturing Process

Label is not available on this site.

07/27/2001 SUPPL-25 Manufacturing (CMC)-Facility

Label is not available on this site.

10/30/2000 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

12/21/1999 SUPPL-22 Manufacturing (CMC)-Facility

Label is not available on this site.

05/20/1999 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/12/1999 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

01/24/1997 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

01/24/1997 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

01/24/1997 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/24/1997 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/02/1994 SUPPL-13 Labeling

Label is not available on this site.

04/03/1992 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

07/30/1991 SUPPL-9 Labeling

Label is not available on this site.

10/27/1989 SUPPL-8 Labeling

Label is not available on this site.

10/10/1989 SUPPL-7 Labeling

Label is not available on this site.

01/03/1990 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/30/1985 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

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