Details for New Drug Application (NDA): 211968
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NDA 211968 describes SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Fresenius Kabi Usa, Fresenius Medcl, Gvs Tm, Hospira, Laboratorios Grifols, Liebel-flarsheim, Otsuka Icu Medcl, Abbott, Baxter Hlthcare, Icu Medical Inc, Jubilant Cadista, Miles, Nephron, and Taro, and is included in twenty-seven NDAs. It is available from twenty-three 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-seven 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-seven suppliers are listed for this compound. Additional details are available on the sodium chloride profile page.
Summary for 211968
| Tradename: | SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
| Applicant: | Nephron |
| Ingredient: | sodium chloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 211968
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | sodium chloride | SOLUTION;INJECTION | 211968 | ANDA | Nephron SC Inc. | 0487-4301 | 0487-4301-05 | 64 BAG in 1 CASE (0487-4301-05) / 50 mL in 1 BAG |
| SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | sodium chloride | SOLUTION;INJECTION | 211968 | ANDA | Nephron SC Inc. | 0487-4301 | 0487-4301-10 | 64 BAG in 1 CASE (0487-4301-10) / 100 mL in 1 BAG |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION | Strength | 450MG/50ML (9MG/ML) | ||||
| Approval Date: | Apr 23, 2020 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION | Strength | 900MG/100ML | ||||
| Approval Date: | Apr 23, 2020 | TE: | AP | RLD: | No | ||||
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