SUBSYS

202788 | Orange Book

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Filed Jan. 4, 2012
Type New Drug Application
Case Type New Drug Application
Ingredients FENTANYL
Dosage Form / Route SPRAY and SUBLINGUAL
PatentExpiration
10,016,4031 year, 9 months from now
10,610,5231 year, 9 months from now
8,835,4591 year, 9 months from now
8,835,4601 year, 9 months from now
9,241,9351 year, 9 months from now
9,289,3871 year, 9 months from now
9,642,7971 year, 9 months from now
9,642,8441 year, 9 months from now
8,486,9725 years from now
8,486,9735 years from now
Last Updated: 14 hours ago
Date Patent / Filing No. Patent and Drug Application Information
4/27/20308486973Expiration of Patent No 8,486,973: TREATMENT OF PAIN (U-55).
4/27/20308486972Expiration of Patent No 8,486,972: (drug product)
1/25/20279642844Expiration of Patent No 9,642,844: (drug product)
1/25/20279642797Expiration of Patent No 9,642,797: TREATMENT OF PAIN (U-55). (drug product)
1/25/20279289387Expiration of Patent No 9,289,387: TREATMENT OF PAIN (U-55). (drug product)
1/25/20279241935Expiration of Patent No 9,241,935: (drug product)
1/25/20278835460Expiration of Patent No 8,835,460: TREATMENT OF PAIN (U-55). (drug product)
1/25/20278835459Expiration of Patent No 8,835,459: (drug product)
1/25/202710610523Expiration of Patent No 10,610,523: (drug product)
1/25/202710016403Expiration of Patent No 10,016,403: (drug product)
12/8/2022SUPPL-30REMS - MODIFIED - D-N-A: Label is not available on this site.
8/17/2022SUPPL-29REMS - MODIFIED - D-N-A: Label is not available on this site.
12/3/2021SUPPL-28REMS - MODIFIED - D-N-A: Label is not available on this site.
3/4/2021SUPPL-23Labeling-Package Insert:
12/23/2020SUPPL-21REMS - MODIFIED - D-N-A: Label is not available on this site.
10/7/2019SUPPL-20Labeling-Medication Guide, Labeling-Package Insert:
9/7/2017SUPPL-18REMS-Proposal: Label is not available on this site.
12/16/2016SUPPL-16Labeling-Medication Guide, Labeling-Package Insert:
11/9/2016SUPPL-17Manufacturing (CMC): Label is not available on this site.
    2/12/2016SUPPL-14Manufacturing (CMC): Label is not available on this site.
      6/9/2015SUPPL-13Manufacturing (CMC): Label is not available on this site.
        12/24/2014SUPPL-12REMS-Modified:
        12/24/2014SUPPL-11Manufacturing (CMC):
        12/24/2014SUPPL-9Labeling-Medication Guide, Labeling-Package Insert:
        11/7/2013SUPPL-10REMS-Modified: Label is not available on this site.
        7/31/2013SUPPL-6Labeling-Container/Carton Labels:
        7/31/2013SUPPL-5Labeling-Package Insert:
        8/30/2012
        Approval for SUBSYS, 1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
        • Reference Drug
        • Active Ingredient: FENTANYL
        • Dosage Form: SPRAY
        • Dosage Route: SUBLINGUAL
        • Therapeutic Equivalence:
        8/30/2012
        Approval for SUBSYS, 1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
        • Reference Drug
        • Active Ingredient: FENTANYL
        • Dosage Form: SPRAY
        • Dosage Route: SUBLINGUAL
        • Therapeutic Equivalence:
        8/30/2012SUPPL-2Labeling-Package Insert:
        6/5/2012SUPPL-3REMS-Modified:
        6/5/2012SUPPL-1Labeling-Container/Carton Labels:
        1/4/2012
        Approval for SUBSYS, 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
        • Reference Drug
        • Active Ingredient: FENTANYL
        • Dosage Form: SPRAY
        • Dosage Route: SUBLINGUAL
        • Therapeutic Equivalence:
        1/4/2012
        Approval for SUBSYS, 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
        • Reference Drug
        • Active Ingredient: FENTANYL
        • Dosage Form: SPRAY
        • Dosage Route: SUBLINGUAL
        • Therapeutic Equivalence:
        1/4/2012
        Approval for SUBSYS, 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
        • Reference Drug
        • Active Ingredient: FENTANYL
        • Dosage Form: SPRAY
        • Dosage Route: SUBLINGUAL
        • Therapeutic Equivalence:
        1/4/2012
        Approval for SUBSYS, 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
        • Reference Drug
        • Active Ingredient: FENTANYL
        • Dosage Form: SPRAY
        • Dosage Route: SUBLINGUAL
        • Therapeutic Equivalence:
        1/4/2012
        Approval for SUBSYS, 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
        • Reference Drug
        • Active Ingredient: FENTANYL
        • Dosage Form: SPRAY
        • Dosage Route: SUBLINGUAL
        • Therapeutic Equivalence:
        1/4/2012ORIG-1Approval: