Last Updated: November 8, 2026

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, Hong Kong, Hospira, Luitpold, Mankind Pharma, Mylan Institutional, Onesource Specialty, Parke Davis, Sagent Pharms Inc, Watson Labs, West-ward Pharms Int, and Wyeth Ayerst, and is included in twenty-two NDAs. It is available from twenty suppliers. Additional details are available on the THIAMINE HYDROCHLORIDE profile page.

The generic ingredient in THIAMINE HYDROCHLORIDE is thiamine hydrochloride. There is one drug master file entry for this compound. Twenty 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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