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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 218471

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NDA 218471 describes THIAMINE HYDROCHLORIDE, which is a drug marketed by Abraxis Pharm, Aspiro, Bel Mar, Caplin, Dell Labs, Dr Reddys, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland, Hospira, Luitpold, Mylan Institutional, Onesource Specialty, Parke Davis, Sagent Pharms Inc, Watson Labs, West-ward Pharms Int, and Wyeth Ayerst, and is included in twenty NDAs. It is available from sixteen suppliers. Additional details are available on the THIAMINE HYDROCHLORIDE profile page.

The generic ingredient in THIAMINE HYDROCHLORIDE is thiamine hydrochloride. There are seven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the thiamine hydrochloride profile page.

Summary for 218471

Tradename:	THIAMINE HYDROCHLORIDE
Applicant:	Aspiro
Ingredient:	thiamine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 218471

Vitamin B Complex

Suppliers and Packaging for NDA: 218471

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
THIAMINE HYDROCHLORIDE	thiamine hydrochloride	INJECTABLE;INJECTION	218471	ANDA	Camber Pharmaceuticals, Inc.	31722-363	31722-363-32	25 VIAL, MULTI-DOSE in 1 TRAY (31722-363-32) / 2 mL in 1 VIAL, MULTI-DOSE (31722-363-31)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	100MG/ML
Approval Date:	Nov 6, 2024	TE:	AP	RLD:	No

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