Details for New Drug Application (NDA): 200674
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NDA 200674 describes LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare Corp, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Farmaceutica, Hospira, Inforlife, and Knack, and is included in eight NDAs. It is available from nine suppliers. Additional details are available on the LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER profile page.
The generic ingredient in LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER is levofloxacin. There are thirty-one drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.
The generic ingredient in LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER is levofloxacin. There are thirty-one drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.
Summary for 200674
| Tradename: | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | levofloxacin |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 200674
Suppliers and Packaging for NDA: 200674
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | levofloxacin | INJECTABLE;INJECTION | 200674 | ANDA | Fresenius Kabi USA, LLC | 63323-355 | 63323-355-50 | 1 BAG in 1 POUCH (63323-355-50) / 50 mL in 1 BAG |
| LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | levofloxacin | INJECTABLE;INJECTION | 200674 | ANDA | Fresenius Kabi USA, LLC | 63323-355 | 63323-355-60 | 1 BAG in 1 POUCH (63323-355-60) / 150 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 250MG/50ML (EQ 5MG/ML) | ||||
| Approval Date: | Jun 19, 2013 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG/100ML (EQ 5MG/ML) | ||||
| Approval Date: | Jun 19, 2013 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 750MG/150ML (EQ 5MG/ML) | ||||
| Approval Date: | Jun 19, 2013 | TE: | AP | RLD: | No | ||||
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