Details for New Drug Application (NDA): 205222
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The generic ingredient in LEVOFLOXACIN is levofloxacin. There are thirty-one drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.
Summary for 205222
Tradename: | LEVOFLOXACIN |
Applicant: | Lannett Co Inc |
Ingredient: | levofloxacin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 205222
Suppliers and Packaging for NDA: 205222
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVOFLOXACIN | levofloxacin | SOLUTION;ORAL | 205222 | ANDA | Lannett Company, Inc. | 0527-1948 | 0527-1948-66 | 1 BOTTLE, PLASTIC in 1 CARTON (0527-1948-66) / 100 mL in 1 BOTTLE, PLASTIC |
LEVOFLOXACIN | levofloxacin | SOLUTION;ORAL | 205222 | ANDA | Lannett Company, Inc. | 0527-1948 | 0527-1948-68 | 1 BOTTLE, PLASTIC in 1 CARTON (0527-1948-68) / 200 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 250MG/10ML | ||||
Approval Date: | May 25, 2018 | TE: | AA | RLD: | No |
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