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Serving 500+ biopharmaceutical companies globally:

Argus Health
Chinese Patent Office
Fish and Richardson
Daiichi Sankyo
Queensland Health
US Department of Justice

Generated: June 28, 2017

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Details for New Drug Application (NDA): 091623

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NDA 091623 describes THIAMINE HYDROCHLORIDE, which is a drug marketed by Abraxis Pharm, Bel Mar, Mylan Institutional, Watson Labs, Wyeth Ayerst, Fresenius Kabi Usa, Luitpold, Akorn, Parke Davis, Dell Labs, West-ward Pharms Int, and Hospira, and is included in fourteen NDAs. It is available from five suppliers. Additional details are available on the THIAMINE HYDROCHLORIDE profile page.

The generic ingredient in THIAMINE HYDROCHLORIDE is thiamine hydrochloride. There are five drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the thiamine hydrochloride profile page.

Summary for NDA: 091623

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 091623

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
thiamine hydrochloride
INJECTABLE;INJECTION 091623 ANDA General Injectables & Vaccines, Inc 52584-196 52584-196-00 1 VIAL, MULTI-DOSE in 1 BAG (52584-196-00) > 2 mL in 1 VIAL, MULTI-DOSE
thiamine hydrochloride
INJECTABLE;INJECTION 091623 ANDA Mylan Institutional LLC 67457-196 67457-196-02 25 VIAL, MULTI-DOSE in 1 CARTON (67457-196-02) > 2 mL in 1 VIAL, MULTI-DOSE (67457-196-00)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/ML
Approval Date:Jun 25, 2012TE:APRLD:No

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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson
Boehringer Ingelheim
Farmers Insurance
Express Scripts
US Department of Justice

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