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Details for New Drug Application (NDA): 021085
NDA 021085 describes AVELOX, which is a drug marketed by Bayer Hlthcare and is included in two NDAs. It is available from seven suppliers. There are two patents 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-four 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-four 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: | 1 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021085
| Ingredient-type | Quinolones |
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 | Schering Plough Corporation | 0085-1733 | 0085-1733-01 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0085-1733-01) |
| AVELOX | moxifloxacin hydrochloride | TABLET;ORAL | 021085 | NDA | Schering Plough Corporation | 0085-1733 | 0085-1733-02 | 50 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0085-1733-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 400MG BASE | ||||
| Approval Date: | Dec 10, 1999 | TE: | AB | RLD: | Yes | ||||
| Regulatory Exclusivity Expiration: | Sep 27, 2019 | ||||||||
| Regulatory Exclusivity Use: | UPDATES TO THE LABELING TO INCLUDE RESULTS OF A TRIAL TO EVALUATE THE SAFETY OF MOXIFLOXACIN IN PEDIATRIC PATIENTS WITH COMPLICATED INTRA-ABDOMINAL INFECTIONS | ||||||||
| Patent: | ➤ Sign Up | Patent Expiration: | Oct 29, 2019 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD OF COMBATING BACTERIA IN A PATIENT | ||||||||
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 | ➤ Sign Up | ➤ Sign Up |
| Bayer Hlthcare | AVELOX | moxifloxacin hydrochloride | TABLET;ORAL | 021085-001 | Dec 10, 1999 | ➤ Sign Up | ➤ Sign Up |
| Bayer Hlthcare | AVELOX | moxifloxacin hydrochloride | TABLET;ORAL | 021085-001 | Dec 10, 1999 | ➤ Sign Up | ➤ Sign Up |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
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