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Last Updated: May 21, 2022

Details for New Drug Application (NDA): 021085


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NDA 021085 describes AVELOX, which is a drug marketed by Bayer Hlthcare and is included in two NDAs. Additional details are available on the AVELOX profile page.

The generic ingredient in AVELOX is moxifloxacin hydrochloride. There are eighteen drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the moxifloxacin hydrochloride profile page.
Summary for 021085
Tradename:AVELOX
Applicant:Bayer Hlthcare
Ingredient:moxifloxacin hydrochloride
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 400MG BASE
Approval Date:Dec 10, 1999TE:RLD:Yes

Expired US Patents for NDA 021085

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare AVELOX moxifloxacin hydrochloride TABLET;ORAL 021085-001 Dec 10, 1999 See Plans and Pricing See Plans and Pricing
Bayer Hlthcare AVELOX moxifloxacin hydrochloride TABLET;ORAL 021085-001 Dec 10, 1999 See Plans and Pricing See Plans and Pricing
Bayer Hlthcare AVELOX moxifloxacin hydrochloride TABLET;ORAL 021085-001 Dec 10, 1999 See Plans and Pricing See Plans and Pricing
Bayer Hlthcare AVELOX moxifloxacin hydrochloride TABLET;ORAL 021085-001 Dec 10, 1999 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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