Details for New Drug Application (NDA): 205540
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The generic ingredient in LEVOFLOXACIN 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 205540
Tradename: | LEVOFLOXACIN |
Applicant: | Gland Pharma Ltd |
Ingredient: | levofloxacin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 205540
Suppliers and Packaging for NDA: 205540
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVOFLOXACIN | levofloxacin | INJECTABLE;INJECTION | 205540 | ANDA | Gland Pharma Limited | 68083-394 | 68083-394-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-394-01) / 20 mL in 1 VIAL, SINGLE-DOSE |
LEVOFLOXACIN | levofloxacin | INJECTABLE;INJECTION | 205540 | ANDA | Gland Pharma Limited | 68083-395 | 68083-395-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-395-01) / 30 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG/20ML (EQ 25MG/ML) | ||||
Approval Date: | Apr 22, 2020 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 750MG/30ML (EQ 25MG/ML) | ||||
Approval Date: | Apr 22, 2020 | TE: | AP | RLD: | No |
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