Details for New Drug Application (NDA): 205833
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NDA 205833 describes MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER, which is a drug marketed by Mylan Labs Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER profile page.
The generic ingredient in MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER is moxifloxacin hydrochloride. There are eighteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the moxifloxacin hydrochloride profile page.
The generic ingredient in MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER is moxifloxacin hydrochloride. There are eighteen drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the moxifloxacin hydrochloride profile page.
Summary for 205833
| Tradename: | MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER |
| Applicant: | Mylan Labs Ltd |
| Ingredient: | moxifloxacin hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 205833
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MOXIFLOXACIN HYDROCHLORIDE IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER | moxifloxacin hydrochloride | SOLUTION;INTRAVENOUS | 205833 | ANDA | Mylan Institutional LLC | 67457-323 | 67457-323-25 | 1 BAG in 1 CARTON (67457-323-25) / 250 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 400MG/250ML (1.6MG/ML) | ||||
| Approval Date: | May 5, 2017 | TE: | RLD: | No | |||||
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