Details for New Drug Application (NDA): 211676
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The generic ingredient in LEVOCARNITINE SF is levocarnitine. There are four drug master file entries for this compound. Eight 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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