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PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER

NDA

CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE | N021703 | VANTIVE US HEALTHCARE LLC

15 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
May 3, 2023	SUPPL -23	View Letter (PDF)
Nov 6, 2018	SUPPL -20	View Letter (PDF)
Jul 5, 2017	SUPPL -18	View Letter (PDF)
Jul 22, 2016	SUPPL -17	View Letter (PDF)
Dec 17, 2015	SUPPL -16	View Letter (PDF)
Jun 12, 2013	SUPPL -10	View Letter (PDF)
Apr 16, 2012	SUPPL -8	View Letter (PDF)
Oct 22, 2008	SUPPL -3	View Letter (PDF)
Oct 27, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (15)

Sort:

#010 — N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 10, 2008

#012 — 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.157GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 10, 2008

#011 — N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 10, 2008

#013 — 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;2.21GM/1000ML;7.07GM/1000ML (5000ML)

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 10, 2008

#006 — 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 25, 2006

#002 — N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 25, 2006

#003 — 5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.157GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 25, 2006

#005 — N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 25, 2006

#015 — N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.44GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 10, 2008

#004 — 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 25, 2006

#008 — 5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;2.03GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 25, 2006

#007 — N/A/1000ML;N/A/1000ML;5.4GM/1000ML;3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 25, 2006

#014 — N/A/1000ML;N/A/1000ML;5.4GM/1000ML;2.44GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 10, 2008

#001 — 5.15GM/1000ML;N/A/1000ML;5.4GM/1000ML;2.03GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Oct 25, 2006

No patent or exclusivity listings for this strength.

#009 — 3.68GM/1000ML;N/A/1000ML;5.4GM/1000ML;3.05GM/1000ML;0.314GM/1000ML;3.09GM/1000ML;6.46GM/1000ML (5000ML)

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Oct 25, 2006