Details for New Drug Application (NDA): 201370
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NDA 201370 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 201370
| Tradename: | HEPARIN SODIUM PRESERVATIVE FREE |
| Applicant: | Pfizer |
| Ingredient: | heparin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 201370
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| HEPARIN SODIUM | heparin sodium | INJECTABLE;INJECTION | 201370 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0043 | 0069-0043-01 | 25 VIAL in 1 CONTAINER (0069-0043-01) / 2 mL in 1 VIAL (0069-0043-02) |
| HEPARIN SODIUM PRESERVATIVE FREE | heparin sodium | INJECTABLE;INJECTION | 201370 | NDA | Pfizer Laboratories Div Pfizer Inc | 0069-0043 | 0069-0043-01 | 25 VIAL in 1 CONTAINER (0069-0043-01) / 2 mL in 1 VIAL (0069-0043-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 1,000 UNITS/ML | ||||
| Approval Date: | Jul 21, 2011 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 5,000 UNITS/ML | ||||
| Approval Date: | Jul 21, 2011 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 10,000 UNITS/ML | ||||
| Approval Date: | Jul 21, 2011 | TE: | RLD: | Yes | |||||
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