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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. It is available from one supplier. There is one patent protecting this drug and one Paragraph IV challenge. 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.
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 |
Suppliers and Packaging for NDA: 021085
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AVELOX | moxifloxacin hydrochloride | TABLET;ORAL | 021085 | NDA AUTHORIZED GENERIC | RedPharm Drug, Inc. | 67296-1299 | 67296-1299-5 | 5 TABLET, FILM COATED in 1 BOTTLE (67296-1299-5) |
Paragraph IV (Patent) Challenges for 021085
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| AVELOX | TABLET;ORAL | moxifloxacin hydrochloride | 021085 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 400MG BASE | ||||
| Approval Date: | Dec 10, 1999 | TE: | 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 | Start Trial | Start Trial |
| Bayer Hlthcare | AVELOX | moxifloxacin hydrochloride | TABLET;ORAL | 021085-001 | Dec 10, 1999 | Start Trial | Start Trial |
| Bayer Hlthcare | AVELOX | moxifloxacin hydrochloride | TABLET;ORAL | 021085-001 | Dec 10, 1999 | Start Trial | Start Trial |
| Bayer Hlthcare | AVELOX | moxifloxacin hydrochloride | TABLET;ORAL | 021085-001 | Dec 10, 1999 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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