Last Updated: September 24, 2026

Details for New Drug Application (NDA): 087968

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NDA 087968 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, 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-one NDAs. It is available from seventeen 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. Seventeen suppliers are listed for this compound. Additional details are available on the thiamine hydrochloride profile page.

Summary for 087968

Tradename:	THIAMINE HYDROCHLORIDE
Applicant:	Epic Pharma Llc
Ingredient:	thiamine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 087968

Vitamin B Complex

Profile for product number 001

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

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