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DECADRON-LA

NDA

DEXAMETHASONE ACETATE | N016675 | MERCK RESEARCH LABORATORIES DIV MERCK CO INC

1 strength0 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain2 active DMFs4 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

EUROAPI FRANCEDEXAMETHASONE ACETATE ANHYDROUS USP

DMF 27361976

PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INCDEXAMETHASONE ACETATE USP ANHYDROUS MICRONIZED

DMF 45321982

DBI INCInactiveDEXAMETHASONE ACETATE

DMF 11421968

ORGANON INCInactiveDEXAMETHASONE ACETATE

DMF 28151976

CYCLO PRODUCTS INCInactiveDEXAMETHASONE ACETATE

DMF 37371980

HOECHST MARION ROUSSEL SAInactiveDEXAMETHASONE ACETATE USP MONOHYDRATE

DMF 115871995

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

Products (1)

#001 — EQ 8MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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.