Details for New Drug Application (NDA): 077857
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NDA 077857 describes ENOXAPARIN SODIUM (PRESERVATIVE FREE), which is a drug marketed by Amphastar Pharm, Be Pharms, Emerge Bioscience, Gland, Sandoz, Shenzhen Techdow, and Zydus Pharms, and is included in seven NDAs. It is available from fifteen suppliers. Additional details are available on the ENOXAPARIN SODIUM (PRESERVATIVE FREE) profile page.
The generic ingredient in ENOXAPARIN SODIUM (PRESERVATIVE FREE) is enoxaparin sodium. There are thirteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the enoxaparin sodium profile page.
The generic ingredient in ENOXAPARIN SODIUM (PRESERVATIVE FREE) is enoxaparin sodium. There are thirteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the enoxaparin sodium profile page.
Summary for 077857
| Tradename: | ENOXAPARIN SODIUM (PRESERVATIVE FREE) |
| Applicant: | Sandoz |
| Ingredient: | enoxaparin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 077857
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 077857 | ANDA | Sandoz Inc | 0781-3238 | 0781-3238-63 | 10 SYRINGE in 1 CARTON (0781-3238-63) / .3 mL in 1 SYRINGE (0781-3238-01) |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 077857 | ANDA | Sandoz Inc | 0781-3246 | 0781-3246-64 | 10 SYRINGE in 1 CARTON (0781-3246-64) / .4 mL in 1 SYRINGE (0781-3246-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 100MG/ML (100MG/ML) | ||||
| Approval Date: | Jul 23, 2010 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 30MG/0.3ML (100MG/ML) | ||||
| Approval Date: | Jul 23, 2010 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 40MG/0.4ML (100MG/ML) | ||||
| Approval Date: | Jul 23, 2010 | TE: | AP | RLD: | No | ||||
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