Details for New Drug Application (NDA): 207956
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NDA 207956 describes SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Fresenius Kabi Usa, Fresenius Medcl, Haemonetics, Hospira, Icu Medical Inc, Laboratorios Grifols, Liebel-flarsheim, Abbott, Baxter Hlthcare, Jubilant Cadista, Miles, Nephron, and Taro, and is included in twenty-seven NDAs. It is available from twenty-one suppliers. Additional details are available on the SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER profile page.
The generic ingredient in SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is sodium chloride. There are one thousand four hundred and seventy-two drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the sodium chloride profile page.
The generic ingredient in SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is sodium chloride. There are one thousand four hundred and seventy-two drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the sodium chloride profile page.
Summary for 207956
| Tradename: | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
| Applicant: | Laboratorios Grifols |
| Ingredient: | sodium chloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 207956
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | sodium chloride | INJECTABLE;INJECTION | 207956 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1609 | 51662-1609-1 | 500 mL in 1 BAG (51662-1609-1) |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | sodium chloride | INJECTABLE;INJECTION | 207956 | ANDA | SOLA Pharmaceuticals, LLC | 70512-841 | 70512-841-06 | 115 BAG in 1 CARTON (70512-841-06) / 50 mL in 1 BAG (70512-841-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 900MG/100ML | ||||
| Approval Date: | May 25, 2017 | TE: | AP | RLD: | No | ||||
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