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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, Eurohlth Intl Sarl, 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

Tradename:
THIAMINE HYDROCHLORIDE
Applicant:
Mylan Institutional
Ingredient:
thiamine hydrochloride
Patents:0
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
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
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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