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TROMETHAMINE

ANDA

TROMETHAMINE | A211558 | B BRAUN MEDICAL INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: THAM(TE code: AP)

Citizen Petitions

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Attachment 3 Proposed Labeling for Ketorolac Tromethamine re Suitability Peti... FDA-2023-P-4518 · 10 docket documents 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	Denied	Senores Pharmaceuticals Inc
Citizen Petition from Arent Fox LLP FDA-2019-P-0692 · 4 docket documents Arent Fox LLP filed this petition on behalf of a client requesting that the FDA Commissioner determine whether Tham Solution (Tromethamine Injection), NDA No. N013025, held by Hospira Inc., was voluntarily withdrawn from the commercial market for safety or effectiveness reasons. The petitioner seeks	505(q)	2019-02-13	Granted	Arent Fox LLP

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

API Supply Chain1 active DMF3 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

BIOSPECTRATROMETHAMINE

DMF 314832017

IMC CHEMICAL GROUP INC SUB INTERNATIONAL MINERALS CHEMICAL CORPInactiveTROMETHAMINE

DMF 4341961

ANGUS CHEMICAL COInactiveTROMETHAMINE (TRIS AMINO)

DMF 105991993

ABBOTT LABORATORIESInactiveTROMETHAMINE,USP

DMF 126351997

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 18GM/500ML (3.6GM/100ML)

0 patents0 exclusivities▴

SOLUTION;INJECTION | Approved: Dec 9, 2024

No patent or exclusivity listings for this strength.