Details for New Drug Application (NDA): 017029
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NDA 017029 describes HEPARIN SODIUM PRESERVATIVE FREE, which is a drug marketed by Dr Reddys, Emerge Bioscience, Fresenius Kabi Usa, Hospira, Pfizer, Pharma Serve Ny, Sagent Pharms, and Shenzhen Techdow, and is included in nine NDAs. It is available from eleven suppliers. Additional details are available on the HEPARIN SODIUM PRESERVATIVE FREE profile page.
The generic ingredient in HEPARIN SODIUM PRESERVATIVE FREE is heparin sodium. There are seventy-seven drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the heparin sodium profile page.
The generic ingredient in HEPARIN SODIUM PRESERVATIVE FREE is heparin sodium. There are seventy-seven drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the heparin sodium profile page.
Summary for 017029
| Tradename: | HEPARIN SODIUM PRESERVATIVE FREE |
| Applicant: | Fresenius Kabi Usa |
| Ingredient: | heparin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 017029
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HEPARIN SODIUM | heparin sodium | INJECTABLE;INJECTION | 017029 | NDA | Henry Schein, Inc. | 0404-9979 | 0404-9979-01 | 1 VIAL, MULTI-DOSE in 1 BAG (0404-9979-01) / 1 mL in 1 VIAL, MULTI-DOSE |
| HEPARIN SODIUM | heparin sodium | INJECTABLE;INJECTION | 017029 | NDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1409 | 51662-1409-1 | 5 mL in 1 VIAL (51662-1409-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1,000 UNITS/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 5,000 UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10,000 UNITS/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
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