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SMOFLIPID 20%

NDA

FISH OIL; MEDIUM CHAIN TRIGLYCERIDES; OLIVE OIL; SOYBEAN OIL | N207648 | FRESENIUS KABI USA LLC

4 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

5 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (100ML)

RLD

0 patents0 exclusivities▴

EMULSION;INTRAVENOUS | Approved: Jul 13, 2016

No patent or exclusivity listings for this strength.

#002 — 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (250ML)

RLD

0 patents0 exclusivities▾

EMULSION;INTRAVENOUS | Approved: Jul 13, 2016

#003 — 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (500ML)

RLD

0 patents0 exclusivities▾

EMULSION;INTRAVENOUS | Approved: Jul 13, 2016

#004 — 3GM/100ML;6GM/100ML;5GM/100ML;6GM/100ML (1000ML)

RLD

0 patents0 exclusivities▾

EMULSION;INTRAVENOUS | Approved: Aug 10, 2018