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Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.

ILOPROST

ANDANot in Orange Book

ILOPROST | A214997 | BELOTECA

API Supply Chain5 active DMFs2 inactive

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

BAYER AGILOPROST

DMF 171702004

EUROAPI HUNGARY LTDILOPROST

DMF 331532018

MSN LABORATORIES PRIVATE LTDILOPROST

DMF 346952020

YS LIFE SCIENCE CO LTDILOPROST

DMF 360222021

CHIROGATE INTERNATIONAL INCILOPROST

DMF 411862025

SCHERING AGInactiveILOPROST

DMF 91401991

BAYER SCHERING PHARMA AGInactiveILOPROST B-CYCLODEXRIN CLATHRATE

DMF 117061995

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

Products (2)

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#001 — 10MCG/ML (10MCG/ML)

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SOLUTION;INHALATION | Approved: Jul. 10, 2026

No patent or exclusivity listings for this strength.

#002 — 20MCG/ML (20MCG/ML)

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SOLUTION;INHALATION | Approved: Jul. 10, 2026