Details for New Drug Application (NDA): 212441
✉ Email this page to a colleague
NDA 212441 describes HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Fresenius Kabi Usa, and Hospira, and is included in four NDAs. It is available from four suppliers. Additional details are available on the HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER profile page.
The generic ingredient in HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is heparin sodium. There are seventy-seven drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the heparin sodium profile page.
The generic ingredient in HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is heparin sodium. There are seventy-seven drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the heparin sodium profile page.
Summary for 212441
| Tradename: | HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | heparin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 212441
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | heparin sodium | INJECTABLE;INJECTION | 212441 | ANDA | Fresenius Kabi USA, LLC | 63323-519 | 63323-519-10 | 12 BAG in 1 CASE (63323-519-10) / 1000 mL in 1 BAG (63323-519-01) |
| HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER | heparin sodium | INJECTABLE;INJECTION | 212441 | ANDA | Fresenius Kabi USA, LLC | 63323-519 | 63323-519-77 | 24 BAG in 1 CASE (63323-519-77) / 500 mL in 1 BAG (63323-519-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 200 UNITS/100ML | ||||
| Approval Date: | Jul 24, 2020 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 200 UNITS/100ML | ||||
| Approval Date: | Jul 24, 2020 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
