Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076858
Company: RISING
Company: RISING
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEVOCARNITINE | LEVOCARNITINE | 330MG | TABLET;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
09/20/2004 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76858ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/17/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
LEVOCARNITINE
TABLET;ORAL; 330MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CARNITOR | LEVOCARNITINE | 330MG | TABLET;ORAL | Prescription | Yes | AB | 018948 | LEADIANT BIOSCI INC |
LEVOCARNITINE | LEVOCARNITINE | 330MG | TABLET;ORAL | Prescription | No | AB | 216384 | NOVITIUM PHARMA |
LEVOCARNITINE | LEVOCARNITINE | 330MG | TABLET;ORAL | Prescription | No | AB | 076858 | RISING |