Details for New Drug Application (NDA): 078990
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NDA 078990 describes ENOXAPARIN SODIUM (PRESERVATIVE FREE), which is a drug marketed by Amphastar Pharm, Be Pharms, Gland, Nanjing King-friend, 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. Seventeen 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. Seventeen suppliers are listed for this compound. Additional details are available on the enoxaparin sodium profile page.
Summary for 078990
| Tradename: | ENOXAPARIN SODIUM (PRESERVATIVE FREE) |
| Applicant: | Gland |
| Ingredient: | enoxaparin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 078990
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 078990 | ANDA | Sagent Pharmaceuticals | 25021-410 | 25021-410-70 | 10 SYRINGE in 1 CARTON (25021-410-70) / .3 mL in 1 SYRINGE |
| ENOXAPARIN SODIUM (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 078990 | ANDA | Sagent Pharmaceuticals | 25021-410 | 25021-410-71 | 10 SYRINGE in 1 CARTON (25021-410-71) / 1 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 30MG/0.3ML (100MG/ML) | ||||
| Approval Date: | Sep 28, 2018 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 40MG/0.4ML (100MG/ML) | ||||
| Approval Date: | Sep 28, 2018 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 60MG/0.6ML (100MG/ML) | ||||
| Approval Date: | Sep 28, 2018 | TE: | AP | RLD: | No | ||||
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