Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

Abbreviated New Drug Application (ANDA): 090403
Company: CADILA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;ORAL Prescription AB No No
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;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
11/15/2010 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
09/18/2019 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

09/18/2019 SUPPL-3 Labeling

Label is not available on this site.

05/09/2016 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

INDOMETHACIN

CAPSULE;ORAL; 25MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;ORAL Prescription No AB 090403 CADILA
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;ORAL Prescription No AB 091276 GLENMARK GENERICS
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;ORAL Prescription No AB 070719 HERITAGE PHARMA
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;ORAL Prescription No AB 018851 HERITAGE PHARMS INC
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;ORAL Prescription No AB 091240 HETERO LABS LTD III
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;ORAL Prescription No AB 205215 JUBILANT GENERICS
INDOMETHACIN INDOMETHACIN 25MG CAPSULE;ORAL Prescription No AB 070673 SANDOZ

CAPSULE;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;ORAL Prescription No AB 090403 CADILA
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;ORAL Prescription No AB 091276 GLENMARK GENERICS
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;ORAL Prescription No AB 070756 HERITAGE PHARMA
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;ORAL Prescription No AB 018851 HERITAGE PHARMS INC
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;ORAL Prescription No AB 091240 HETERO LABS LTD III
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;ORAL Prescription No AB 205215 JUBILANT GENERICS
INDOMETHACIN INDOMETHACIN 50MG CAPSULE;ORAL Prescription No AB 070674 SANDOZ

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