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AMMONUL

NDA

SODIUM BENZOATE; SODIUM PHENYLACETATE | N020645 | BAUSCH HEALTH US LLC

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Dec 23, 2020	SUPPL -12	View Letter (PDF)
Jul 5, 2011	SUPPL -8	View Letter (PDF)
Feb 23, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10%;10% (5GM/50ML;5GM/50ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Feb 17, 2005

No patent or exclusivity listings for this strength.