Details for New Drug Application (NDA): 091387
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NDA 091387 describes BALANCED SALT, which is a drug marketed by B Braun and Epic Pharma Llc and is included in two NDAs. It is available from one supplier. Additional details are available on the BALANCED SALT profile page.
The generic ingredient in BALANCED SALT is calcium chloride; magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium citrate. There are two hundred and eighty-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the calcium chloride; magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium citrate profile page.
The generic ingredient in BALANCED SALT is calcium chloride; magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium citrate. There are two hundred and eighty-two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the calcium chloride; magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium citrate profile page.
Summary for 091387
| Tradename: | BALANCED SALT |
| Applicant: | B Braun |
| Ingredient: | calcium chloride; magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium citrate |
| Patents: | 0 |
Pharmacology for NDA: 091387
Suppliers and Packaging for NDA: 091387
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BALANCED SALT | calcium chloride; magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium citrate | SOLUTION;IRRIGATION | 091387 | ANDA | B. Braun Medical Inc. | 0264-1945 | 0264-1945-10 | 500 mL in 1 BAG (0264-1945-10) |
| BALANCED SALT | calcium chloride; magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium citrate | SOLUTION;IRRIGATION | 091387 | ANDA | B. Braun Medical Inc. | 0264-2514 | 0264-2514-10 | 500 mL in 1 BOTTLE, GLASS (0264-2514-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;IRRIGATION | Strength | 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML | ||||
| Approval Date: | Feb 3, 2010 | TE: | AT | RLD: | No | ||||
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