Details for New Drug Application (NDA): 201043
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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 201043
Tradename: | LEVOFLOXACIN |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | levofloxacin |
Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 201043
Suppliers and Packaging for NDA: 201043
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVOFLOXACIN | levofloxacin | TABLET;ORAL | 201043 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-457 | 43063-457-02 | 2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-02) |
LEVOFLOXACIN | levofloxacin | TABLET;ORAL | 201043 | ANDA | PD-Rx Pharmaceuticals, Inc. | 43063-457 | 43063-457-03 | 3 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-457-03) |
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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