Details for New Drug Application (NDA): 091436
✉ Email this page to a colleague
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 091436
Tradename: | LEVOFLOXACIN |
Applicant: | Baxter Hlthcare Corp |
Ingredient: | levofloxacin |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 091436
Suppliers and Packaging for NDA: 091436
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVOFLOXACIN | levofloxacin | INJECTABLE;INJECTION | 091436 | ANDA | Baxter Healthcare Corporation | 36000-045 | 36000-045-01 | 20 mL in 1 VIAL, SINGLE-USE (36000-045-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG/20ML (EQ 25MG/ML) | ||||
Approval Date: | Jun 5, 2013 | TE: | RLD: | No |
Complete Access Available with Subscription