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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

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.

API Supply Chain1 active DMF2 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

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.