Details for New Drug Application (NDA): 206908
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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-seven suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.
Summary for 206908
Tradename: | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER |
Applicant: | Gland Pharma Ltd |
Ingredient: | levofloxacin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 206908
Suppliers and Packaging for NDA: 206908
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | levofloxacin | INJECTABLE;INJECTION | 206908 | ANDA | Gland Pharma Limited | 68083-414 | 68083-414-01 | 1 BAG in 1 POUCH (68083-414-01) / 50 mL in 1 BAG |
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | levofloxacin | INJECTABLE;INJECTION | 206908 | ANDA | Gland Pharma Limited | 68083-415 | 68083-415-01 | 1 BAG in 1 POUCH (68083-415-01) / 100 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: | Dec 30, 2020 | 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: | Dec 30, 2020 | 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: | Dec 30, 2020 | TE: | AP | RLD: | No |
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