JANUMET XR

202270 | Orange Book

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Filed Feb. 2, 2012
Type New Drug Application
Case Type New Drug Application
Ingredients METFORMIN HYDROCHLORIDE and SITAGLIPTIN PHOSPHATE
Dosage Form / Route ORAL and TABLET, EXTENDED RELEASE
PatentExpiration
6,699,8712 years, 8 months ago
7,125,8732 years, 8 months ago
6,699,8712 years, 2 months ago
7,125,8732 years, 2 months ago
7,326,7081 year, 7 months from now
7,326,7082 years, 1 month from now
Last Updated: 2 years, 8 months ago
Date Patent / Filing No. Patent and Drug Application Information
5/24/20277326708Expiration of Patent No 7,326,708: Has Pediatrict Exclusivity.
11/24/20267326708Expiration of Patent No 7,326,708: (U-1227). (drug product)
1/26/20237125873Expiration of Patent No 7,125,873: Has Pediatrict Exclusivity.
1/26/20236699871Expiration of Patent No 6,699,871: Has Pediatrict Exclusivity.
7/26/20227125873Expiration of Patent No 7,125,873: (U-1227). (drug product)
7/26/20226699871Expiration of Patent No 6,699,871: (U-1227). (drug product)
6/21/2022SUPPL-26Labeling-Package Insert:
11/4/2021SUPPL-25Labeling-Package Insert:
12/4/2020SUPPL-22Efficacy-Labeling Change With Clinical Data:
8/12/2019SUPPL-19Efficacy-Labeling Change With Clinical Data:
7/1/2019SUPPL-20Labeling-Package Insert:
2/9/2018SUPPL-18Labeling-Package Insert:
8/10/2017SUPPL-17Labeling-Package Insert:
1/18/2017SUPPL-16Labeling-Package Insert, Labeling-Medication Guide:
1/18/2017SUPPL-15Labeling-Package Insert:
8/28/2015SUPPL-10Labeling-Medication Guide:
4/27/2015SUPPL-9Labeling-Package Insert:
9/19/2014SUPPL-8Manufacturing (CMC): Label is not available on this site.
    2/12/2014SUPPL-6Labeling-Medication Guide:
    10/17/2013SUPPL-5Manufacturing (CMC): Label is not available on this site.
      7/19/2013SUPPL-4Manufacturing (CMC): Label is not available on this site.
        4/10/2013SUPPL-1Manufacturing (CMC): Label is not available on this site.
          2/11/2013SUPPL-3Labeling-Container/Carton Labels, Labeling-Medication Guide:
          10/18/2012SUPPL-2Labeling-Medication Guide:
          2/2/2012
          Approval for JANUMET XR, 1GM;EQ 100MG BASE
          • Reference Drug
          • Active Ingredient: METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
          • Dosage Form: TABLET, EXTENDED RELEASE
          • Dosage Route: ORAL
          • Therapeutic Equivalence:
          2/2/2012
          Approval for JANUMET XR, 1GM;EQ 50MG BASE
          • Reference Drug
          • Active Ingredient: METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
          • Dosage Form: TABLET, EXTENDED RELEASE
          • Dosage Route: ORAL
          • Therapeutic Equivalence:
          2/2/2012
          Approval for JANUMET XR, 500MG;EQ 50MG BASE
          • Reference Drug
          • Active Ingredient: METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
          • Dosage Form: TABLET, EXTENDED RELEASE
          • Dosage Route: ORAL
          • Therapeutic Equivalence:
          2/2/2012ORIG-1Approval: