Details for New Drug Application (NDA): 212533
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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 212533
Tradename: | LEVOCARNITINE |
Applicant: | Sciegen Pharms Inc |
Ingredient: | levocarnitine |
Patents: | 0 |
Suppliers and Packaging for NDA: 212533
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LEVOCARNITINE | levocarnitine | SOLUTION;ORAL | 212533 | ANDA | TRUPHARMA, LLC | 52817-830 | 52817-830-04 | 118 mL in 1 BOTTLE (52817-830-04) |
LEVOCARNITINE | levocarnitine | SOLUTION;ORAL | 212533 | ANDA | Saptalis Pharmaceuticals, LLC | 71656-016 | 71656-016-01 | 100 CUP, UNIT-DOSE in 1 TRAY (71656-016-01) / 5 mL in 1 CUP, UNIT-DOSE (71656-016-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | 1GM/10ML | ||||
Approval Date: | Nov 10, 2021 | TE: | AA | RLD: | No |
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