Details for New Drug Application (NDA): 205540
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NDA 205540 describes LEVOFLOXACIN, which is a drug marketed by Avet Lifesciences, Baxter Hlthcare Corp, Eugia Pharma, Gland Pharma Ltd, Hospira, Norvium Bioscience, Rising, Zydus Pharms, Micro Labs Ltd India, Rubicon, Sciegen Pharms Inc, Watson Labs Teva, Lannett Co Inc, Novitium Pharma, Anda Repository, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Molecular, Dr Reddys Labs Inc, Glenmark Pharms Ltd, Hec Pharm, Hetero Labs Ltd V, Jubilant Generics, Lupin, Macleods Pharms Ltd, Natco Pharma, Orbion Pharms, Sandoz, Teva, Torrent Pharms, Watson Labs Inc, Zydus Lifesciences, Fresenius Kabi Usa, Hikma Farmaceutica, Inforlife, and Knack, and is included in forty-three NDAs. It is available from forty-two suppliers. Additional details are available on the LEVOFLOXACIN profile page.
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.
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 205540
| Tradename: | LEVOFLOXACIN |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | levofloxacin |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 205540
Suppliers and Packaging for NDA: 205540
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEVOFLOXACIN | levofloxacin | INJECTABLE;INJECTION | 205540 | ANDA | Gland Pharma Limited | 68083-394 | 68083-394-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-394-01) / 20 mL in 1 VIAL, SINGLE-DOSE |
| LEVOFLOXACIN | levofloxacin | INJECTABLE;INJECTION | 205540 | ANDA | Gland Pharma Limited | 68083-395 | 68083-395-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (68083-395-01) / 30 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 500MG/20ML (EQ 25MG/ML) | ||||
| Approval Date: | Apr 22, 2020 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 750MG/30ML (EQ 25MG/ML) | ||||
| Approval Date: | Apr 22, 2020 | TE: | AP | RLD: | No | ||||
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