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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=209222&event=overview.process&utm_medium=&utm_source=
Submission: On December 21 via manual from US — Scanned from DE
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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): 209222 Company: ALKEM LABS LTD * Email PRODUCTS ON ANDA 209222 CSVExcelPrint Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;10MG TABLET;ORAL Prescription AB No No EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;20MG TABLET;ORAL Prescription AB No No EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;40MG TABLET;ORAL Prescription AB No No EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;80MG TABLET;ORAL Prescription AB No No Showing 1 to 4 of 4 entries APPROVAL DATE(S) AND HISTORY, LETTERS, LABELS, REVIEWS FOR ANDA 209222 ORIGINAL APPROVALS OR TENTATIVE APPROVALS CSVExcelPrint Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan Status Letters, Reviews, Labels, Patient Package InsertNotes 12/22/2017 ORIG-1 Approval STANDARD 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 12/16/2022 SUPPL-12 Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert Label is not available on this site. 02/23/2021 SUPPL-8 Labeling-Package Insert Label is not available on this site. 01/29/2020 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert Label is not available on this site. 09/26/2019 SUPPL-5 Labeling-Package Insert Label is not available on this site. 04/16/2019 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert Label is not available on this site. Showing 1 to 5 of 5 entries THERAPEUTIC EQUIVALENTS FOR ANDA 209222 EZETIMIBE AND SIMVASTATIN TABLET;ORAL; 10MG;10MG TE Code = AB CSVExcelPrint Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;10MG TABLET;ORAL Prescription No AB 209222 ALKEM LABS LTD EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;10MG TABLET;ORAL Prescription No AB 208831 AMNEAL PHARMS CO EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;10MG TABLET;ORAL Prescription No AB 200909 DR REDDYS LABS SA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;10MG TABLET;ORAL Prescription No AB 208699 GLENMARK PHARMS LTD EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;10MG TABLET;ORAL Prescription No AB 202968 WATSON LABS INC VYTORIN EZETIMIBE; SIMVASTATIN 10MG;10MG TABLET;ORAL Prescription Yes AB 021687 ORGANON Showing 1 to 6 of 6 entries TABLET;ORAL; 10MG;20MG TE Code = AB CSVExcelPrint Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;20MG TABLET;ORAL Prescription No AB 209222 ALKEM LABS LTD EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;20MG TABLET;ORAL Prescription No AB 208831 AMNEAL PHARMS CO EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;20MG TABLET;ORAL Prescription No AB 200909 DR REDDYS LABS SA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;20MG TABLET;ORAL Prescription No AB 208699 GLENMARK PHARMS LTD EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;20MG TABLET;ORAL Prescription No AB 202968 WATSON LABS INC VYTORIN EZETIMIBE; SIMVASTATIN 10MG;20MG TABLET;ORAL Prescription Yes AB 021687 ORGANON Showing 1 to 6 of 6 entries TABLET;ORAL; 10MG;40MG TE Code = AB CSVExcelPrint Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;40MG TABLET;ORAL Prescription No AB 209222 ALKEM LABS LTD EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;40MG TABLET;ORAL Prescription No AB 208831 AMNEAL PHARMS CO EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;40MG TABLET;ORAL Prescription No AB 200909 DR REDDYS LABS SA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;40MG TABLET;ORAL Prescription No AB 208699 GLENMARK PHARMS LTD EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;40MG TABLET;ORAL Prescription No AB 202968 WATSON LABS INC VYTORIN EZETIMIBE; SIMVASTATIN 10MG;40MG TABLET;ORAL Prescription Yes AB 021687 ORGANON Showing 1 to 6 of 6 entries TABLET;ORAL; 10MG;80MG TE Code = AB CSVExcelPrint Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;80MG TABLET;ORAL Prescription No AB 209222 ALKEM LABS LTD EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;80MG TABLET;ORAL Prescription No AB 208831 AMNEAL PHARMS CO EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;80MG TABLET;ORAL Prescription No AB 200909 DR REDDYS LABS SA EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;80MG TABLET;ORAL Prescription No AB 208699 GLENMARK PHARMS LTD EZETIMIBE AND SIMVASTATIN EZETIMIBE; SIMVASTATIN 10MG;80MG TABLET;ORAL Prescription No AB 202968 WATSON LABS INC VYTORIN EZETIMIBE; SIMVASTATIN 10MG;80MG TABLET;ORAL Prescription Yes AB 021687 ORGANON Showing 1 to 6 of 6 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