Last Updated: June 24, 2026

Details for New Drug Application (NDA): 208703

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NDA 208703 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 seventeen 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. Seventeen suppliers are listed for this compound. Additional details are available on the thiamine hydrochloride profile page.

Summary for 208703

Tradename:	THIAMINE HYDROCHLORIDE
Applicant:	Eugia Pharma
Ingredient:	thiamine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 208703

Vitamin B Complex

Suppliers and Packaging for NDA: 208703

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
THIAMINE HYDROCHLORIDE	thiamine hydrochloride	INJECTABLE;INJECTION	208703	ANDA	Eugia US LLC	55150-273	55150-273-25	25 VIAL, MULTI-DOSE in 1 CARTON (55150-273-25) / 2 mL in 1 VIAL, MULTI-DOSE (55150-273-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	100MG/ML
Approval Date:	Apr 20, 2022	TE:	AP	RLD:	No

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