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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204879

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NDA 204879 describes PYRIDOXINE HYDROCHLORIDE, which is a drug marketed by Akorn, Bel Mar, Dell Labs, Elkins Sinn, Fresenius Kabi Usa, Luitpold, Mylan Institutional, and Watson Labs, and is included in ten NDAs. It is available from two suppliers. Additional details are available on the PYRIDOXINE HYDROCHLORIDE profile page.

The generic ingredient in PYRIDOXINE HYDROCHLORIDE is pyridoxine hydrochloride. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the pyridoxine hydrochloride profile page.

Summary for 204879

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 204879

Medical Subject Heading (MeSH) Categories for 204879

Suppliers and Packaging for NDA: 204879

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PYRIDOXINE HYDROCHLORIDE pyridoxine hydrochloride INJECTABLE;INJECTION 204879 ANDA Mylan Institutional LLC 67457-281 67457-281-01 25 VIAL, MULTI-DOSE in 1 CARTON (67457-281-01) > 1 mL in 1 VIAL, MULTI-DOSE (67457-281-00)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/ML
Approval Date:Jul 14, 2016TE:APRLD:No


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