Details for New Drug Application (NDA): 077438
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The generic ingredient in LEVOFLOXACIN is levofloxacin. There are thirty-one drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.
Summary for 077438
Tradename: | LEVOFLOXACIN |
Applicant: | Sandoz |
Ingredient: | levofloxacin |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Medical Subject Heading (MeSH) Categories for 077438
Suppliers and Packaging for NDA: 077438
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVOFLOXACIN | levofloxacin | TABLET;ORAL | 077438 | ANDA | Sandoz Inc | 0781-5790 | 0781-5790-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0781-5790-01) |
LEVOFLOXACIN | levofloxacin | TABLET;ORAL | 077438 | ANDA | Sandoz Inc | 0781-5790 | 0781-5790-10 | 1000 TABLET, FILM COATED in 1 BOTTLE (0781-5790-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Jun 20, 2011 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Jun 20, 2011 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 750MG | ||||
Approval Date: | Jun 20, 2011 | TE: | AB | RLD: | No |
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