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HEXADROL

NDA

DEXAMETHASONE SODIUM PHOSPHATE | N014694 | ASPEN GLOBAL INC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from GeneYork Pharmaceuticals Group LLC FDA-2018-P-0614 GeneYork Pharmaceuticals, LLC filed this citizen petition on February 7, 2018 requesting that the FDA designate ANDA 084916 owned by Fresenius Kabi USA, Inc. as an alternate reference standard for the discontinued referenced listed drug HEXADROL (Dexamethasone Sodium Phosphate Injection) originally	505(q)	2018-02-08	Denied	GeneYork Pharmaceuticals Group LLC

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain8 active DMFs5 inactive

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

EUROAPI FRANCEDEXAMETHASONE SODIUM PHOSPHATE

DMF 39631980

PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INCDEXAMETHASONE SODIUM PHOSPHATE USP

DMF 65251986

SYMBIOTICA SPECIALITY INGREDIENTS SDN BHDDEXAMETHASONE SODIUM PHOSPHATE

DMF 242152010

CURIA SPAIN SAUDEXAMETHASONE SODIUM PHOSPHATE

DMF 294122015

XIAN GUOKANG RUIJIN PHARMACEUTICAL CO LTDDEXAMETHASONE SODIUM PHOSPHATE

DMF 362692022

HENAN LIHUA PHARMACEUTICAL CO LTDDEXAMETHASONE SODIUM PHOSPHATE

DMF 392592024

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDDEXAMETHASONE SODIUM PHOSPHATE

DMF 417282025

SYMBIOTEC PHARMALAB PRIVATE LIMITEDDEXAMETHASONE SODIUM PHOSPHATE USP

DMF 424652025

DIOSYNTH BVInactiveDEXAMETHASONE SODIUM PHOSPHATE

DMF 38411980

SOCIETA ITALIANA CORTICOSTEROIDI SPAInactiveDEXAMETHASONE SODIUM PHOSPHATE

DMF 59711985

QUATRUMInactiveDEXAMETHASONE SODIUM PHOSPHATE

DMF 72251987

MAHIMA LIFE SCIENCES PRIVATE LTDInactiveDEXAMETHASONE SODIUM PHOSPHATE USP

DMF 226472008

TIANJIN TIANYAO PHARMACEUTICALS CO LTDInactiveDEXAMETHASONE SODIUM PHOSPHATE

DMF 271952013

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jun 7, 2024	SUPPL -31	View Letter (PDF)
Jul 17, 2014	SUPPL -30	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#002 — EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#003 — EQ 10MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

#004 — EQ 20MG PHOSPHATE/ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982