Details for New Drug Application (NDA): 208600
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NDA 208600 describes ENOXAPARIN SODIUM, which is a drug marketed by Amphastar Pharms Inc, Nanjing King-friend, Sandoz Inc, Amphastar Pharm, Be Pharms, Gland, Sandoz, Shenzhen Techdow, and Zydus Pharms, and is included in ten NDAs. It is available from three suppliers. Additional details are available on the ENOXAPARIN SODIUM profile page.
The generic ingredient in ENOXAPARIN SODIUM 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 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 208600
| Tradename: | ENOXAPARIN SODIUM |
| Applicant: | Amphastar Pharms Inc |
| Ingredient: | enoxaparin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 208600
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ENOXAPARIN SODIUM | enoxaparin sodium | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 208600 | ANDA | Amphastar Pharmaceuticals, Inc. | 0548-5608 | 0548-5608-00 | 1 VIAL in 1 CARTON (0548-5608-00) / 3 mL in 1 VIAL |
| ENOXAPARIN SODIUM | enoxaparin sodium | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 208600 | ANDA | BluePoint Laboratories | 68001-464 | 68001-464-41 | 1 VIAL in 1 CARTON (68001-464-41) / 3 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Strength | 300MG/3ML (100MG/ML) | ||||
| Approval Date: | Mar 14, 2019 | TE: | AB | RLD: | No | ||||
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