Details for New Drug Application (NDA): 212060
NDA 212060 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 is one drug master file entry for this compound. Twenty-four 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 is one drug master file entry for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the heparin sodium profile page.
Summary for 212060
| Tradename: | HEPARIN SODIUM PRESERVATIVE FREE |
| Applicant: | Emerge Bioscience |
| Ingredient: | heparin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 212060
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HEPARIN SODIUM PRESERVATIVE FREE | heparin sodium | INJECTABLE;INJECTION | 212060 | ANDA | Meitheal Pharmaceuticals Inc. | 71288-405 | 71288-405-81 | 24 BLISTER PACK in 1 CARTON (71288-405-81) / 1 SYRINGE, GLASS in 1 BLISTER PACK (71288-405-80) / .5 mL in 1 SYRINGE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10,000 UNITS/ML | ||||
| Approval Date: | Apr 2, 2020 | TE: | AP | RLD: | No | ||||
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