Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 075861
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

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 WEST-WARD PHARMS INT

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