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Submission: On December 21 via manual from US — Scanned from DE
Effective URL: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?ApplNo=075861&event=overview.process&utm_medium=&utm_source=
Submission: On December 21 via manual from US — Scanned from DE
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* Skip to main content * Skip to FDA Search * Skip to footer links An official website of the United States government Here's how you know The .gov means it's official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site. The site is secure. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. U.S. FOOD AND DRUG ADMINISTRATION * Search * Menu Search FDA Submit search FEATURED * Contact FDA * FDA Guidance Documents * Recalls, Market Withdrawals and Safety Alerts * Press Announcements * Warning Letters * Advisory Committees * En Español PRODUCTS * Food * Drugs * Medical Devices * Radiation-Emitting Products * Vaccines, Blood, and Biologics * Animal and Veterinary * Cosmetics * Tobacco Products TOPICS * About FDA * Combination Products * Regulatory Information * Safety * Emergency Preparedness * International Programs * News and Events * Training and Continuing Education * Inspections and Compliance * Science and Research INFORMATION FOR * Consumers * Patients * Industry * Health Professionals * Federal, State and Local Officials 1. Home 2. Drug Databases 3. Drugs@FDA DRUGS@FDA: FDA-APPROVED DRUGS * Share * Tweet * Linkedin * Email * Print Home | Previous Page Abbreviated New Drug Application (ANDA): 075861 Company: AM REGENT * Email PRODUCTS ON ANDA 075861 CSVExcelPrint Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS LEVOCARNITINE LEVOCARNITINE 200MG/ML INJECTABLE;INJECTION Prescription AP No No Showing 1 to 1 of 1 entries APPROVAL DATE(S) AND HISTORY, LETTERS, LABELS, REVIEWS FOR ANDA 075861 ORIGINAL APPROVALS OR TENTATIVE APPROVALS CSVExcelPrint Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan Status Letters, Reviews, Labels, Patient Package InsertNotes 06/22/2001 ORIG-1 Approval Letter (PDF) Label is not available on this site. Showing 1 to 1 of 1 entries SUPPLEMENTS CSVExcelPrint Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package Insert Note 12/15/2022 SUPPL-11 Labeling-Container/Carton Labels Label is not available on this site. Showing 1 to 1 of 1 entries THERAPEUTIC EQUIVALENTS FOR ANDA 075861 LEVOCARNITINE INJECTABLE;INJECTION; 200MG/ML TE Code = AP CSVExcelPrint Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication 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 Showing 1 to 3 of 3 entries FOOTER LINKS * FDA Archive * About FDA * Accessibility * Visitor Information * Website Policies / Privacy * No FEAR Act * Vulnerability Disclosure Policy * FOIA * HHS.gov * USA.gov Contact FDA Follow FDA on Facebook Follow FDA on Twitter View FDA videos on YouTube Subscribe to FDA RSS feeds FDA Homepage Contact Number 1-888-INFO-FDA (1-888-463-6332) Back to Top