Details for New Drug Application (NDA): 211676
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NDA 211676 describes LEVOCARNITINE SF, which is a drug marketed by Novitium Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the LEVOCARNITINE SF profile page.
The generic ingredient in LEVOCARNITINE SF 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 SF 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 211676
| Tradename: | LEVOCARNITINE SF |
| Applicant: | Novitium Pharma |
| Ingredient: | levocarnitine |
| Patents: | 0 |
Suppliers and Packaging for NDA: 211676
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEVOCARNITINE | levocarnitine | SOLUTION;ORAL | 211676 | ANDA | ANI Pharmaceuticals, Inc. | 70954-139 | 70954-139-10 | 118 mL in 1 BOTTLE (70954-139-10) |
| LEVOCARNITINE | levocarnitine | SOLUTION;ORAL | 211676 | ANDA | ANI Pharmaceuticals, Inc. | 70954-140 | 70954-140-10 | 118 mL in 1 BOTTLE (70954-140-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 1GM/10ML | ||||
| Approval Date: | Aug 14, 2019 | TE: | AA | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 1GM/10ML | ||||
| Approval Date: | Aug 14, 2019 | TE: | AA | RLD: | No | ||||
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