Testing version — LOERadar is in active testing. Features and data may change.

CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER (AMINO ACIDS; DEXTROSE) | LOERadar

Viewing data from:

CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER

NDA

AMINO ACIDS; DEXTROSE | N020734 | BAXTER HEALTHCARE CORP

13 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

8 letters from Drugs@FDA

Date	Submission	Document
Apr 14, 2021	SUPPL -37	View Letter (PDF)
Oct 21, 2016	SUPPL -25	View Letter (PDF)
Jan 20, 2010	SUPPL -19	View Letter (PDF)
Feb 2, 2004	SUPPL -13	View Letter (PDF)
Jun 8, 2003	SUPPL -12	View Letter (PDF)
Jul 25, 2002	SUPPL -11	View Letter (PDF)
Jul 25, 2002	SUPPL -10	View Letter (PDF)
Apr 12, 2000	SUPPL -3	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (13)

Sort:

#002 — 2.75%;10GM/100ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Sep 29, 1997

#005 — 2.75%;25GM/100ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Sep 29, 1997

#001 — 2.75%;5GM/100ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Sep 29, 1997

No patent or exclusivity listings for this strength.

#008 — 4.25%;10GM/100ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Sep 29, 1997

#010 — 4.25%;20GM/100ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Sep 29, 1997

#011 — 4.25%;25GM/100ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Sep 29, 1997

#007 — 4.25%;5GM/100ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Sep 29, 1997

#014 — 5%;10GM/100ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Sep 29, 1997

#015 — 5%;15GM/100ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Sep 29, 1997

#016 — 5%;20GM/100ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Sep 29, 1997

#017 — 5%;25GM/100ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Sep 29, 1997

#018 — 5%;35GM/100ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Sep 29, 1997

#019 — 8%;14GM/100ML

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Apr 13, 2021