Details for New Drug Application (NDA): 216123
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NDA 216123 describes STERILE WATER FOR IRRIGATION, which is a drug marketed by Fresenius Kabi Usa and is included in one NDA. It is available from two suppliers. Additional details are available on the STERILE WATER FOR IRRIGATION profile page.
The generic ingredient in STERILE WATER FOR IRRIGATION is sterile water for irrigation. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the sterile water for irrigation profile page.
The generic ingredient in STERILE WATER FOR IRRIGATION is sterile water for irrigation. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the sterile water for irrigation profile page.
Summary for 216123
| Tradename: | STERILE WATER FOR IRRIGATION |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | sterile water for irrigation |
| Patents: | 0 |
Suppliers and Packaging for NDA: 216123
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| STERILE WATER FOR IRRIGATION | sterile water for irrigation | LIQUID;IRRIGATION | 216123 | ANDA | Becton Dickinson and Company | 17271-802 | 17271-802-07 | 6 BAG in 1 CASE (17271-802-07) / 1000 mL in 1 BAG |
| STERILE WATER FOR IRRIGATION | sterile water for irrigation | LIQUID;IRRIGATION | 216123 | ANDA | Becton Dickinson and Company | 17271-802 | 17271-802-08 | 5 BAG in 1 CASE (17271-802-08) / 2000 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | LIQUID;IRRIGATION | Strength | 100% | ||||
| Approval Date: | Aug 12, 2024 | TE: | AT | RLD: | No | ||||
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