Details for New Drug Application (NDA): 018948
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NDA 018948 describes CARNITOR, which is a drug marketed by Leadiant Biosci Inc and is included in three NDAs. It is available from two suppliers. Additional details are available on the CARNITOR profile page.
The generic ingredient in CARNITOR 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 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 018948
| Tradename: | CARNITOR |
| Applicant: | Leadiant Biosci Inc |
| Ingredient: | levocarnitine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 018948
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARNITOR | levocarnitine | SOLUTION;ORAL | 018948 | NDA | Akorn | 50383-172 | 50383-172-90 | 9 BLISTER PACK in 1 CARTON (50383-172-90) / 10 TABLET in 1 BLISTER PACK |
| CARNITOR | levocarnitine | SOLUTION;ORAL | 018948 | NDA | Leadiant Biosciences, Inc. | 54482-144 | 54482-144-07 | 10 BLISTER PACK in 1 CARTON (54482-144-07) / 9 TABLET in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 330MG | ||||
| Approval Date: | Dec 27, 1985 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | 1GM/10ML | ||||
| Approval Date: | Apr 27, 1988 | TE: | RLD: | No | |||||
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