Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 071469
Company: ANI PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MECLOFENAMATE SODIUM MECLOFENAMATE SODIUM EQ 100MG BASE CAPSULE;ORAL Discontinued None No No
MECLOFENAMATE SODIUM MECLOFENAMATE SODIUM EQ 50MG BASE 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
04/15/1987 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
04/28/2021 SUPPL-24 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

05/09/2016 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

04/25/2001 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1998 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

10/21/1994 SUPPL-18 Labeling

Label is not available on this site.

04/29/1996 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/12/1993 SUPPL-16 Labeling

Label is not available on this site.

06/25/1992 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

01/28/1991 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

08/07/1991 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

04/17/1989 SUPPL-11 Labeling

Label is not available on this site.

02/14/1989 SUPPL-10 Labeling

Label is not available on this site.

08/29/1988 SUPPL-9 Labeling

Label is not available on this site.

07/12/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/12/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/12/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/06/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

11/06/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English