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): 200529
Company: CHARTWELL RX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INDOMETHACIN INDOMETHACIN 75MG CAPSULE, EXTENDED RELEASE;ORAL Prescription AB 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
11/30/2010 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
05/12/2021 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

05/10/2021 SUPPL-3 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

05/09/2016 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

INDOMETHACIN

CAPSULE, EXTENDED RELEASE;ORAL; 75MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INDOMETHACIN INDOMETHACIN 75MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 091549 AMNEAL PHARMS
INDOMETHACIN INDOMETHACIN 75MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 079175 AVANTHI INC
INDOMETHACIN INDOMETHACIN 75MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 200529 CHARTWELL RX
INDOMETHACIN INDOMETHACIN 75MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 203501 GLENMARK PHARMS LTD
INDOMETHACIN INDOMETHACIN 75MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 201807 HETERO LABS LTD III
INDOMETHACIN INDOMETHACIN 75MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 204853 NOVAST LABS
INDOMETHACIN INDOMETHACIN 75MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 074464 SANDOZ
INDOMETHACIN INDOMETHACIN 75MG CAPSULE, EXTENDED RELEASE;ORAL Prescription No AB 202711 ZYDUS PHARMS
Back to Top