Details for New Drug Application (NDA): 020164
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The generic ingredient in LOVENOX (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 020164
| Tradename: | LOVENOX (PRESERVATIVE FREE) |
| Applicant: | Sanofi Aventis Us |
| Ingredient: | enoxaparin sodium |
| Patents: | 0 |
Suppliers and Packaging for NDA: 020164
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LOVENOX | enoxaparin sodium | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 020164 | NDA | Sanofi-Aventis U.S. LLC | 0075-0620 | 0075-0620-40 | 10 CELLO PACK in 1 CARTON (0075-0620-40) / 1 SYRINGE in 1 CELLO PACK (0075-0620-01) / .4 mL in 1 SYRINGE |
| LOVENOX | enoxaparin sodium | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 020164 | NDA | Sanofi-Aventis U.S. LLC | 0075-0621 | 0075-0621-60 | 10 CELLO PACK in 1 CARTON (0075-0621-60) / 1 SYRINGE in 1 CELLO PACK (0075-0621-01) / .6 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: | Mar 29, 1993 | TE: | AP | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 40MG/0.4ML (100MG/ML) | ||||
| Approval Date: | Jan 30, 1998 | TE: | AP | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;SUBCUTANEOUS | Strength | 60MG/0.6ML (100MG/ML) | ||||
| Approval Date: | Mar 27, 1998 | TE: | AP | RLD: | Yes | ||||
Expired US Patents for NDA 020164
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Sanofi Aventis Us | LOVENOX (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 020164-003 | Mar 27, 1998 | 4,692,435 | ⤷ Start Trial |
| Sanofi Aventis Us | LOVENOX (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 020164-001 | Mar 29, 1993 | 4,692,435 | ⤷ Start Trial |
| Sanofi Aventis Us | LOVENOX (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 020164-007 | Jun 2, 2000 | 4,692,435 | ⤷ Start Trial |
| Sanofi Aventis Us | LOVENOX (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 020164-007 | Jun 2, 2000 | 4,486,420 | ⤷ Start Trial |
| Sanofi Aventis Us | LOVENOX (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 020164-003 | Mar 27, 1998 | RE38743 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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