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BSS PLUS

NDA

CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE | N018469 | ALCON LABORATORIES 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

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Apr 14, 2023	SUPPL -60	View Letter (PDF)
Apr 28, 2016	SUPPL -56	View Letter (PDF)
Dec 22, 2015	SUPPL -54	View Letter (PDF)
Dec 22, 2015	SUPPL -55	View Letter (PDF)
Dec 30, 2004	SUPPL -41	View Letter (PDF)
Dec 30, 2004	SUPPL -40	View Letter (PDF)
May 27, 2004	SUPPL -38	View Letter (PDF)
May 27, 2004	SUPPL -39	View Letter (PDF)
Jul 28, 2003	SUPPL -37	View Letter (PDF)
Jul 28, 2003	SUPPL -36	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/ML;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/ML

RLD

0 patents0 exclusivities▴

SOLUTION;IRRIGATION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.