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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 080553

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NDA 080553 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 080553

Tradename:	THIAMINE HYDROCHLORIDE
Applicant:	Wyeth Ayerst
Ingredient:	thiamine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 080553

Vitamin B Complex

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	100MG/ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

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