Details for New Drug Application (NDA): 205323
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NDA 205323 describes HEPARIN SODIUM, which is a drug marketed by Abraxis Pharm, Aspen Global Inc, B Braun Medical, Be Pharms, Casi Pharms Inc, Chamberlin Parenterl, Dell Labs, Dr Reddys, Emerge Bioscience, Epic Pharma Llc, Fresenius Kabi Usa, Gland, Hikma, Hospira, Hospira Inc, Lilly, Luitpold, Parke Davis, Pfizer, Pharm Spec, Pharmacia And Upjohn, Pharmobedient, Plano Pharms, Sagent Pharms, Shenzhen Techdow, Smith And Nephew, Solopak, Watson Labs Inc, Baxter Hlthcare, Mcgaw, B Braun, and Pharma Serve Ny, and is included in sixty-nine NDAs. It is available from twenty-two suppliers. Additional details are available on the HEPARIN SODIUM profile page.
The generic ingredient in HEPARIN SODIUM 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 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 205323
| Tradename: | HEPARIN SODIUM |
| Applicant: | Gland |
| Ingredient: | heparin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 205323
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HEPARIN SODIUM | heparin sodium | INJECTABLE;INJECTION | 205323 | ANDA | Gland Pharma Limited | 68083-136 | 68083-136-25 | 25 VIAL in 1 CARTON (68083-136-25) / 1 mL in 1 VIAL (68083-136-01) |
| HEPARIN SODIUM | heparin sodium | INJECTABLE;INJECTION | 205323 | ANDA | Gland Pharma Limited | 68083-427 | 68083-427-25 | 25 VIAL, MULTI-DOSE in 1 CARTON (68083-427-25) / 10 mL in 1 VIAL, MULTI-DOSE (68083-427-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5,000 UNITS/ML | ||||
| Approval Date: | Feb 6, 2017 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1,000 UNITS/ML | ||||
| Approval Date: | Nov 18, 2019 | TE: | AP | RLD: | No | ||||
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