Details for New Drug Application (NDA): 211188
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NDA 211188 describes STERILE WATER FOR INJECTION, which is a drug marketed by Am Regent, Fresenius Kabi Usa, Hikma, Hospira, Medefil Inc, Nephron, Nexus, B Braun, Baxter Hlthcare, Otsuka Icu Medcl, and Taro, and is included in fifteen NDAs. It is available from sixteen suppliers. Additional details are available on the STERILE WATER FOR INJECTION profile page.
The generic ingredient in STERILE WATER FOR INJECTION is sterile water for injection. There are one thousand and seventy-two drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the sterile water for injection profile page.
The generic ingredient in STERILE WATER FOR INJECTION is sterile water for injection. There are one thousand and seventy-two drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the sterile water for injection profile page.
Summary for 211188
| Tradename: | STERILE WATER FOR INJECTION |
| Applicant: | Medefil Inc |
| Ingredient: | sterile water for injection |
| Patents: | 0 |
Suppliers and Packaging for NDA: 211188
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| STERILE WATER FOR INJECTION | sterile water for injection | LIQUID;N/A | 211188 | ANDA | Medefil, Inc. | 64253-020 | 64253-020-21 | 60 SYRINGE, PLASTIC in 1 BOX (64253-020-21) / 1 mL in 1 SYRINGE, PLASTIC |
| STERILE WATER FOR INJECTION | sterile water for injection | LIQUID;N/A | 211188 | ANDA | Medefil, Inc. | 64253-020 | 64253-020-23 | 60 SYRINGE, PLASTIC in 1 BOX (64253-020-23) / 3 mL in 1 SYRINGE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | LIQUID;N/A | Strength | 100% (1ML) | ||||
| Approval Date: | Dec 2, 2019 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | LIQUID;N/A | Strength | 100% (2.5ML) | ||||
| Approval Date: | Dec 2, 2019 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | LIQUID;N/A | Strength | 100% (3ML) | ||||
| Approval Date: | Dec 2, 2019 | TE: | RLD: | No | |||||
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