Details for New Drug Application (NDA): 203851
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NDA 203851 describes HEPARIN SODIUM, which is a drug marketed by Abraxis Pharm, Aspen Global Inc, B Braun Medical Inc, Be Pharms, Casi Pharms Inc, Chamberlin Parenterl, Dell Labs, Dr Reddys, Epic Pharma Llc, Fresenius Kabi Usa, Gland, Hikma, Hospira, Hospira Inc, Lilly, Luitpold, Mylan Labs Ltd, Nanjing King-friend, Parke Davis, Pfizer, Pharm Spec, Pharmacia And Upjohn, Sagent Pharms, Sandoz, 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 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-two 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-two suppliers are listed for this compound. Additional details are available on the heparin sodium profile page.
Summary for 203851
| Tradename: | HEPARIN SODIUM |
| Applicant: | Mylan Labs Ltd |
| Ingredient: | heparin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 203851
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HEPARIN SODIUM | heparin sodium | INJECTABLE;INJECTION | 203851 | ANDA | Henry Schein, Inc. | 0404-9873 | 0404-9873-01 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9873-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| HEPARIN SODIUM | heparin sodium | INJECTABLE;INJECTION | 203851 | ANDA | Mylan Institutional LLC | 67457-372 | 67457-372-99 | 25 VIAL, SINGLE-DOSE in 1 CARTON (67457-372-99) / 1 mL in 1 VIAL, SINGLE-DOSE (67457-372-12) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 1,000 UNITS/ML | ||||
| Approval Date: | Nov 30, 2017 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5,000 UNITS/ML | ||||
| Approval Date: | Nov 30, 2017 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10,000 UNITS/ML | ||||
| Approval Date: | Nov 30, 2017 | TE: | AP | RLD: | No | ||||
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