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MIDAZOLAM HYDROCHLORIDE (AUTOINJECTOR)

NDA

MIDAZOLAM HYDROCHLORIDE | N216359 | RAFA LABORATORIES LTD

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 Chain1 active DMF

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

CAMBREX PROFARMACO MILANO SRLMIDAZOLAM HYDROCHLORIDE

DMF 399912024

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 18, 2024	SUPPL -2	View Letter (PDF)
Aug 9, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 10MG BASE/0.7ML (EQ 10MG BASE/0.7ML)

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAMUSCULAR | Approved: Aug 8, 2022

No patent or exclusivity listings for this strength.