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DEXMEDETOMIDINE HYDROCHLORIDE

ANDA

DEXMEDETOMIDINE HYDROCHLORIDE | A218675 | KNACK PHARMACEUTICALS INC

1 strength0 unique patents0 unique exclusivities

API Supply Chain16 active DMFs1 inactive

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

FERMION OYDEXMEDETOMIDINE HYDROCHLORIDE

DMF 138101998

STERLING WISCONSIN LLCDEXMEDETOMIDINE HYDROCHLORIDE USP (FP-071)

DMF 226812009

GLAND PHARMA LTDDEXMEDETOMIDINE HYDROCHLORIDE USP

DMF 232322009

ASYMCHEM LABORATORIES TIANJIN CO LTDDEXMEDETOMIDINE HYDROCHLORIDE

DMF 262232012

JIANGSU HENGRUI PHARMACEUTICALS CO LTDDEXMEDETOMIDINE HYDROCHLORIDE USP, NON-STERILE, BULK DRUG SUBSTANCE

DMF 263772012

INTERQUIM SA DE CVDEXMEDETOMIDINE HYDROCHLORIDE

DMF 278832014

EMCURE PHARMACEUTICALS LTDDEXMEDETOMIDINE HYDROCHLORIDE USP

DMF 280782014

GLAND PHARMA LTDDEXMEDETOMIDINE HYDROCHLORIDE USP

DMF 286082014

MOEHS IBERICA SLDEXMEDETOMIDINE HYDROCHLORIDE

DMF 334042018

MOEHS IBERICA SLDEXMEDETOMIDINE HYDROCHLORIDE

DMF 364782022

GUANG'AN KINGDAY PHARMA AND CHEM CO LTDDEXMEDETOMIDINE HYDROCHLORIDE

DMF 366812022

ASCENSUS SPECIALTIES LLCDEXMEDETOMIDINE HYDROCHLORIDE USP

DMF 382482023

MAITHRI DRUGS PRIVATE LTDDEXMEDETOMIDINE HYDROCHLORIDE USP

DMF 387612023

YANGTZE RIVER PHARMACEUTICAL GROUP JIANGSU HAICI BIOLOGICAL PHARMACEUTICAL CO LTDDEXMEDETOMIDINE HYDROCHLORIDE NON-STERILE DRUG SUBSTANCE

DMF 397752024

JIANGSU CHIA TAI FENGHAI PHARMACEUTICAL CO LTDDEXMEDETOMIDINE HYDROCHLORIDE

DMF 407512024

HUBEI BIOCAUSE HEILEN PHARMACEUTICAL CO LTDDEXMEDETOMIDINE HYDROCHLORIDE USP

DMF 426572025

ORION CORP LTDInactiveDEXMEDETOMIDINE

DMF 92511991

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

Products (1)

#001 — EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Mar 9, 2026

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDtype7/1/2026

Dexmedetomidine Hydrochloride (NDA 218675) transitioned from prescription status to discontinued product status.

Old: RX

New: DISCN

MODIFIEDTE Code7/1/2026

Knack's dexmedetomidine hydrochloride (NDA 218675) therapeutic equivalence code changed from AP to a new classification.

Old: AP