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THAM-E

NDA

POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE | N013025 | HOSPIRA INC

2 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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment 3 Proposed Labeling for Ketorolac Tromethamine re Suitability Peti... FDA-2023-P-4518 Senores Pharmaceuticals Inc filed a suitability petition regarding proposed labeling for ketorolac tromethamine. The petition requests FDA determination on the acceptability of the proposed labeling for this nonsteroidal anti-inflammatory drug product.	Suitability	2023-10-16	Open	Senores Pharmaceuticals Inc

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 21, 2006	SUPPL -40	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#002 — 18GM/500ML (3.6GM/100ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLDAP

0 patents0 exclusivities▾

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

#001 — 370MG/VIAL;1.75GM/VIAL;36GM/VIAL

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.