Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075567
Company: HIKMA
Company: HIKMA
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 |
---|---|---|---|---|---|---|---|
03/29/2001 | ORIG-1 | Approval |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-567_Levocarnitine_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75567ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-567_Levocarnitine.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/04/2002 | SUPPL-2 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
07/23/2001 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
03/29/2001 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75-567_Levocarnitine_prntlbl.pdf |
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 |