Details for New Drug Application (NDA): 020635
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NDA 020635 describes LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by Janssen Pharms and is included in one NDA. Additional details are available on the LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER profile page.
The generic ingredient in LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER is levofloxacin. There are thirty-one drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.
The generic ingredient in LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER is levofloxacin. There are thirty-one drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.
Summary for 020635
| Tradename: | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
| Applicant: | Janssen Pharms |
| Ingredient: | levofloxacin |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 020635
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG/20ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 20, 1996 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 250MG/50ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 20, 1996 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG/100ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 20, 1996 | TE: | RLD: | Yes | |||||
Expired US Patents for NDA 020635
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Janssen Pharms | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | levofloxacin | INJECTABLE;INJECTION | 020635-002 | Dec 20, 1996 | ⤷ Subscribe | ⤷ Subscribe |
| Janssen Pharms | LEVAQUIN | levofloxacin | INJECTABLE;INJECTION | 020635-001 | Dec 20, 1996 | ⤷ Subscribe | ⤷ Subscribe |
| Janssen Pharms | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | levofloxacin | INJECTABLE;INJECTION | 020635-003 | Dec 20, 1996 | ⤷ Subscribe | ⤷ Subscribe |
| Janssen Pharms | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | levofloxacin | INJECTABLE;INJECTION | 020635-003 | Dec 20, 1996 | ⤷ Subscribe | ⤷ Subscribe |
| Janssen Pharms | LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER | levofloxacin | INJECTABLE;INJECTION | 020635-002 | Dec 20, 1996 | ⤷ Subscribe | ⤷ Subscribe |
| Janssen Pharms | LEVAQUIN | levofloxacin | INJECTABLE;INJECTION | 020635-004 | Dec 20, 1996 | ⤷ Subscribe | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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