Details for New Drug Application (NDA): 076684
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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 076684
Tradename: | ENOXAPARIN SODIUM (PRESERVATIVE FREE) |
Applicant: | Amphastar Pharm |
Ingredient: | enoxaparin sodium |
Patents: | 0 |
Suppliers and Packaging for NDA: 076684
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ENOXAPARIN SODIUM (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 076684 | ANDA | Amphastar Pharmaceuticals, Inc. | 0548-5601 | 0548-5601-00 | 10 SYRINGE in 1 CARTON (0548-5601-00) / .3 mL in 1 SYRINGE |
ENOXAPARIN SODIUM (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 076684 | ANDA | Amphastar Pharmaceuticals, Inc. | 0548-5602 | 0548-5602-00 | 10 SYRINGE in 1 CARTON (0548-5602-00) / .4 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 19, 2011 | 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 19, 2011 | 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 19, 2011 | TE: | AP | RLD: | No |
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