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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 080575


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NDA 080575 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 080575
Tradename:THIAMINE HYDROCHLORIDE
Applicant:West-ward Pharms Int
Ingredient:thiamine hydrochloride
Patents:0
Medical Subject Heading (MeSH) Categories for 080575
Vitamin B Complex
Suppliers and Packaging for NDA: 080575
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
THIAMINE HYDROCHLORIDE thiamine hydrochloride INJECTABLE;INJECTION 080575 ANDA Hikma Pharmaceuticals USA Inc. 0641-6228 0641-6228-25 25 VIAL in 1 CARTON (0641-6228-25) / 2 mL in 1 VIAL (0641-6228-01)
THIAMINE HYDROCHLORIDE thiamine hydrochloride INJECTABLE;INJECTION 080575 ANDA REMEDYREPACK INC. 70518-4230 70518-4230-0 25 VIAL in 1 CARTON (70518-4230-0) / 2 mL in 1 VIAL (70518-4230-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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