Details for New Drug Application (NDA): 020164
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NDA 020164 describes LOVENOX (PRESERVATIVE FREE), which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from four suppliers. Additional details are available on the LOVENOX (PRESERVATIVE FREE) profile page.
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.
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 | 020164-004 | Mar 27, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Sanofi Aventis Us | LOVENOX (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 020164-003 | Mar 27, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Sanofi Aventis Us | LOVENOX (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 020164-003 | Mar 27, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Sanofi Aventis Us | LOVENOX | enoxaparin sodium | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 020164-009 | Jan 23, 2003 | ⤷ Sign Up | ⤷ Sign Up |
| Sanofi Aventis Us | LOVENOX (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 020164-005 | Mar 27, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Sanofi Aventis Us | LOVENOX (PRESERVATIVE FREE) | enoxaparin sodium | INJECTABLE;SUBCUTANEOUS | 020164-006 | Jun 2, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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