Viewing data from:

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.

ROMIDEPSIN

ANDANot in Orange Book

ROMIDEPSIN | A220783 | ZYDUS PHARMS

API Supply Chain3 active DMFs1 inactive

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

CONCORD BIOTECH LTDROMIDEPSIN

DMF 273992013

TAPI NL BVROMIDEPSIN

DMF 274002013

MSN LABORATORIES PRIVATE LTDROMIDEPSIN

DMF 334972019

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveROMIDEPSIN

DMF 332352018

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

Products (1)

#001 — 10MG/VIAL

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POWDER;INTRAVENOUS | Approved: Oct. 19, 2026

No patent or exclusivity listings for this strength.