Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075861
Company: AM REGENT
Company: AM REGENT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
LEVOCARNITINE | LEVOCARNITINE | 200MG/ML | INJECTABLE;INJECTION | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
06/22/2001 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75861ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/25/2023 | SUPPL-12 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
12/15/2022 | SUPPL-11 | Labeling-Container/Carton Labels |
Label is not available on this site. |
LEVOCARNITINE
INJECTABLE;INJECTION; 200MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CARNITOR | LEVOCARNITINE | 200MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 020182 | LEADIANT BIOSCI INC |
LEVOCARNITINE | LEVOCARNITINE | 200MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075861 | AM REGENT |
LEVOCARNITINE | LEVOCARNITINE | 200MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075567 | HIKMA |