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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088640
Company: BARR
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MEPERIDINE HYDROCHLORIDE MEPERIDINE HYDROCHLORIDE 100MG 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
09/19/1984 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-50 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/18/2023 SUPPL-49 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/18/2023 SUPPL-48 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/17/2023 SUPPL-47 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

07/17/2023 SUPPL-43 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-42 REMS - PROPOSAL - D-N-A

Label is not available on this site.

07/17/2023 SUPPL-41 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/29/2015 SUPPL-37 Labeling-Package Insert

Label is not available on this site.

05/29/2015 SUPPL-36 Labeling-Package Insert

Label is not available on this site.

09/02/2009 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

03/02/2004 SUPPL-29 Labeling

Label is not available on this site.

07/09/2001 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

07/09/2001 SUPPL-27 Manufacturing (CMC)-Facility

Label is not available on this site.

10/30/2000 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

12/21/1999 SUPPL-24 Manufacturing (CMC)-Facility

Label is not available on this site.

05/20/1999 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

03/12/1999 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

12/01/1998 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

10/04/1996 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

10/04/1996 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

10/04/1996 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/04/1996 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

03/02/1994 SUPPL-15 Labeling

Label is not available on this site.

04/03/1992 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

09/27/1991 SUPPL-11 Labeling

Label is not available on this site.

08/30/1991 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

08/30/1991 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

10/27/1989 SUPPL-8 Labeling

Label is not available on this site.

08/28/1989 SUPPL-7 Labeling

Label is not available on this site.

04/01/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/02/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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