Details for New Drug Application (NDA): 019257
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NDA 019257 describes CARNITOR SF, which is a drug marketed by Leadiant Biosci Inc and is included in one NDA. It is available from one supplier. Additional details are available on the CARNITOR SF profile page.
The generic ingredient in CARNITOR SF is levocarnitine. There are four drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the levocarnitine profile page.
The generic ingredient in CARNITOR SF is levocarnitine. There are four drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the levocarnitine profile page.
Summary for 019257
| Tradename: | CARNITOR SF |
| Applicant: | Leadiant Biosci Inc |
| Ingredient: | levocarnitine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 019257
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARNITOR | levocarnitine | SOLUTION;ORAL | 019257 | NDA | Leadiant Biosciences, Inc. | 54482-145 | 54482-145-08 | 24 BOTTLE, PLASTIC in 1 CASE (54482-145-08) / 118 mL in 1 BOTTLE, PLASTIC |
| CARNITOR | levocarnitine | SOLUTION;ORAL | 019257 | NDA | Leadiant Biosciences, Inc. | 54482-145 | 54482-145-09 | 24 BOTTLE, PLASTIC in 1 CASE (54482-145-09) / 118 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 1GM/10ML | ||||
| Approval Date: | Apr 10, 1986 | TE: | AA | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 1GM/10ML | ||||
| Approval Date: | Mar 28, 2007 | TE: | AA | RLD: | Yes | ||||
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