Details for New Drug Application (NDA): 075861
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NDA 075861 describes LEVOCARNITINE, which is a drug marketed by Am Regent, Hikma, Teva Pharms Usa, Novitium Pharma, Rising, and Sciegen Pharms Inc, and is included in nine NDAs. It is available from six suppliers. Additional details are available on the LEVOCARNITINE profile page.
The generic ingredient in LEVOCARNITINE is levocarnitine. There are four drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the levocarnitine profile page.
The generic ingredient in LEVOCARNITINE is levocarnitine. There are four drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the levocarnitine profile page.
Summary for 075861
| Tradename: | LEVOCARNITINE |
| Applicant: | Am Regent |
| Ingredient: | levocarnitine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 075861
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEVOCARNITINE | levocarnitine | INJECTABLE;INJECTION | 075861 | ANDA | American Regent, Inc. | 0517-1045 | 0517-1045-05 | 5 VIAL, SINGLE-DOSE in 1 CARTON (0517-1045-05) / 5 mL in 1 VIAL, SINGLE-DOSE (0517-1045-01) |
| LEVOCARNITINE | levocarnitine | INJECTABLE;INJECTION | 075861 | ANDA | American Regent, Inc. | 0517-1075 | 0517-1075-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0517-1075-01) / 20 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 200MG/ML | ||||
| Approval Date: | Jun 22, 2001 | TE: | AP | RLD: | No | ||||
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