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INDOMETHACIN

ANDA

INDOMETHACIN | A215399 | AMNEAL PHARMACEUTICALS LLC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Wiley Rein LLP FDA-2025-P-6089 · 49 docket documents Wiley Rein LLP filed this citizen petition on behalf of an unnamed client requesting that the FDA take immediate action regarding generic indomethacin suppositories distributed under ANDA 21589942 by Hikma Pharmaceutical USA Inc. and ANDA 21539943 by Amneal Pharmaceuticals LLC. The petition requests	505(q) Stay Request	2025-11-14	Open	Wiley Rein LLP

Source: Regulations.gov. FDA citizen petitions matched by application number.

API Supply Chain6 active DMFs6 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

FIS FABBRICA ITALIANA SINTETICI SPAINDOMETHACIN

DMF 31361978

MACLEODS PHARMACEUTICALS LTDINDOMETHACIN

DMF 217402008

CSPC OUYI PHARMACEUTICAL CO LTDINDOMETHACIN

DMF 219842008

HETERO DRUGS LTDINDOMETHACIN

DMF 363642021

AURORE LIFE SCIENCES PRIVATE LTDINDOMETHACIN USP

DMF 367612022

AGNO PHARMAINDOMETHACIN USP

DMF 376382024

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPAInactiveINDOMETHACIN

DMF 26331976

ESTEVE QUIMICA SAInactiveINDOMETHACIN FOR HUMAN USE

DMF 42201981

SIGMA F AND D DIV LTDInactiveINDOMETHACIN

DMF 52581983

EURAND AMERICA INCInactiveINDOMETHACIN

DMF 59781985

SHANGHAI NO 17 PHARMACEUTICAL FACTORYInactiveINDOMETHACIN

DMF 74941988

GUANGDONG PHARMACEUTICAL FACTORYInactiveINDOMETHACIN

DMF 85811990

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 50MG

0 patents0 exclusivities▴

SUPPOSITORY;RECTAL | Approved: Feb 24, 2025

No patent or exclusivity listings for this strength.