Details for New Drug Application (NDA): 018948
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The generic ingredient in CARNITOR 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 018948
Tradename: | CARNITOR |
Applicant: | Leadiant Biosci Inc |
Ingredient: | levocarnitine |
Patents: | 0 |
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 | Leadiant Biosciences, Inc. | 54482-144 | 54482-144-07 | 10 BLISTER PACK in 1 CARTON (54482-144-07) / 9 TABLET in 1 BLISTER PACK |
CARNITOR | levocarnitine | TABLET;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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