Details for New Drug Application (NDA): 205968
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The generic ingredient in LEVOFLOXACIN 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 205968
Tradename: | LEVOFLOXACIN |
Applicant: | Zydus Pharms |
Ingredient: | levofloxacin |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 205968
Suppliers and Packaging for NDA: 205968
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVOFLOXACIN | levofloxacin | INJECTABLE;INJECTION | 205968 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-989 | 68382-989-20 | 20 mL in 1 VIAL (68382-989-20) |
LEVOFLOXACIN | levofloxacin | INJECTABLE;INJECTION | 205968 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-989 | 68382-989-30 | 30 mL in 1 VIAL (68382-989-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG/20ML (EQ 25MG/ML) | ||||
Approval Date: | Jun 1, 2017 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 750MG/30ML (EQ 25MG/ML) | ||||
Approval Date: | Jun 1, 2017 | TE: | RLD: | No |
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