Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Newly Added Patents

About This List
  • This screen lists the current month's NEW ADDITIONS or NEW CHANGES to the patents for drugs listed in the Orange Book.
  • This list will be purged after the Cumulative Supplement to the Orange Book is published on the first day of the next month. All the information listed on this screen is also available by using the other Orange Book search methods, such as searching by Proprietary Name.
  • Patents will remain available in the Orange Book even when they are no longer listed as NEW additions or NEW changes.
Additional Information about Patents
  • Patent information is published on or after the submission date as defined in 21 CFR 314.53(d)(5).
  • Patent listings published prior to August 18, 2003, only identify method-of-use claims. The listed patents may include drug substance and/or drug product claims that are not indicated in the listing.
  • As of December 5, 2016, an NDA holder submitting information on a patent that claims both the drug substance and the drug product (and is eligible for listing on either basis) is required only to specify that it claims either the drug substance or the drug product. Orange Book users should not rely on an Orange Book patent listing, regardless of when first published, to determine the range of patent claims that may be asserted by an NDA holder or patent owner.
260 records returned
Appl No Active Ingredient Proprietary Name Dosage Form Route Strength Patent No Patent Expire Date Drug Substance Drug Product Patent Use Code Delist Requested Mkt. Status Submission Date
Appl No Active Ingredient Proprietary Name Dosage Form Route Strength Patent No Patent Expire Date Drug Substance Drug Product Patent Use Code Delist Requested Mkt. Status Submission Date
N202192 RUXOLITINIB PHOSPHATE JAKAFI TABLET ORAL EQ 10MG BASE 9662335 12/12/2026 DS Y RX 06/29/2017
N207202 ARIPIPRAZOLE ABILIFY MYCITE KIT TABLET ORAL 20MG 10097388 09/19/2034 U-2169 RX 11/05/2018
N202834 PERAMPANEL FYCOMPA TABLET ORAL 10MG 6949571 06/08/2021 DS DP U-106 RX 11/19/2012
N202834 PERAMPANEL FYCOMPA TABLET ORAL 10MG 8772497 07/01/2026 DS RX 08/06/2014
N210045 AMLODIPINE BESYLATE; CELECOXIB CONSENSI TABLET ORAL EQ 2.5MG BASE;200MG 9662315 02/28/2030 DP U-2410 RX 10/16/2018
N208276 TREPROSTINIL REMODULIN SOLUTION INTRAVENOUS, SUBCUTANEOUS 50MG/20ML (2.5MG/ML) 9593066 12/15/2028 DS RX 11/02/2018
N209022 FLUTICASONE PROPIONATE XHANCE SPRAY, METERED NASAL 0.093MG 10076614 10/20/2034 DP RX 10/12/2018
N205832 NINTEDANIB ESYLATE OFEV CAPSULE ORAL EQ 150MG BASE 10105323 06/04/2029 DP RX 11/06/2018
N208276 TREPROSTINIL REMODULIN SOLUTION INTRAVENOUS, SUBCUTANEOUS 20MG/20ML (1MG/ML) 9604901 12/15/2028 DS RX 11/02/2018
N208276 TREPROSTINIL REMODULIN SOLUTION INTRAVENOUS, SUBCUTANEOUS 20MG/20ML (1MG/ML) 10076505 12/16/2024 DP RX 11/02/2018
N202834 PERAMPANEL FYCOMPA TABLET ORAL 10MG 6949571 06/08/2021 DS DP U-2089 RX 11/19/2012
N206627 HYDROCODONE BITARTRATE HYSINGLA TABLET, EXTENDED RELEASE ORAL 120MG 9572804 10/30/2020 DP RX 03/23/2017
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 4MG BASE 8530694 08/06/2027 DS DP U-1780 RX 12/14/2015
N208276 TREPROSTINIL REMODULIN SOLUTION INTRAVENOUS, SUBCUTANEOUS 20MG/20ML (1MG/ML) 9593066 12/15/2028 DS RX 11/02/2018
N022103 TROSPIUM CHLORIDE SANCTURA XR CAPSULE, EXTENDED RELEASE ORAL 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** 7410978 02/01/2025 DP Y DISCN
N022103 TROSPIUM CHLORIDE SANCTURA XR CAPSULE, EXTENDED RELEASE ORAL 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** 7763635 11/04/2024 U-1071 Y DISCN
N202834 PERAMPANEL FYCOMPA TABLET ORAL 4MG 6949571 06/08/2021 DS DP U-2089 RX 11/19/2012
N202834 PERAMPANEL FYCOMPA TABLET ORAL 12MG 6949571 06/08/2021 DS DP U-106 RX 11/19/2012
N207999 OBETICHOLIC ACID OCALIVA TABLET ORAL 5MG 10052337 04/26/2036 DP RX 11/08/2018
N208276 TREPROSTINIL REMODULIN SOLUTION INTRAVENOUS, SUBCUTANEOUS 50MG/20ML (2.5MG/ML) 9713599 12/16/2024 U-2036 RX 11/02/2018
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 4MG BASE 9233115 08/12/2024 U-2434 RX 02/08/2016
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 4MG BASE 8871745 08/06/2027 U-2434 RX 12/14/2015
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 4MG BASE 8530694 08/06/2027 DS DP U-2434 RX 12/14/2015
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 4MG BASE 9175017 06/16/2029 U-2434 RX 12/14/2015
N207999 OBETICHOLIC ACID OCALIVA TABLET ORAL 10MG 10052337 04/26/2036 DP RX 11/08/2018
N202834 PERAMPANEL FYCOMPA TABLET ORAL 12MG 8772497 07/01/2026 DS RX 08/06/2014
N202834 PERAMPANEL FYCOMPA TABLET ORAL 12MG 6949571 06/08/2021 DS DP U-2089 RX 11/19/2012
N206185 LATANOPROST XELPROS EMULSION OPHTHALMIC 0.005% 9539262 10/15/2028 DP U-2400 RX 09/25/2018
N209606 ENASIDENIB MESYLATE IDHIFA TABLET ORAL EQ 50MG BASE 10093654 08/01/2034 DS DP U-2087 RX 11/07/2018
N202880 HYDROCODONE BITARTRATE ZOHYDRO ER CAPSULE, EXTENDED RELEASE ORAL 10MG 10092559 09/12/2034 U-55 RX 11/13/2018
N208276 TREPROSTINIL REMODULIN SOLUTION INTRAVENOUS, SUBCUTANEOUS 50MG/20ML (2.5MG/ML) 10076505 12/16/2024 DP RX 11/02/2018
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 4MG BASE 7442830 08/06/2027 DS DP U-1780 RX 12/14/2015
N208276 TREPROSTINIL REMODULIN SOLUTION INTRAVENOUS, SUBCUTANEOUS 20MG/20ML (1MG/ML) 9713599 12/16/2024 U-2036 RX 11/02/2018
N022103 TROSPIUM CHLORIDE SANCTURA XR CAPSULE, EXTENDED RELEASE ORAL 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** 7781448 11/04/2024 U-1071 Y DISCN
N208276 TREPROSTINIL REMODULIN SOLUTION INTRAVENOUS, SUBCUTANEOUS 100MG/20ML (5MG/ML) 9713599 12/16/2024 U-2036 RX 11/02/2018
N209863 TESTOSTERONE ENANTHATE XYOSTED (AUTOINJECTOR) SOLUTION SUBCUTANEOUS 100MG/0.5ML (100MG/0.5ML) RE44846 08/10/2019 DP DISCN 10/24/2018
N209863 TESTOSTERONE ENANTHATE XYOSTED (AUTOINJECTOR) SOLUTION SUBCUTANEOUS 100MG/0.5ML (100MG/0.5ML) 9744302 11/19/2035 DP DISCN 10/24/2018
N202834 PERAMPANEL FYCOMPA TABLET ORAL 10MG 6949571 06/08/2021 DS DP U-2428 RX 11/19/2012
N208276 TREPROSTINIL REMODULIN SOLUTION INTRAVENOUS, SUBCUTANEOUS 50MG/20ML (2.5MG/ML) 9604901 12/15/2028 DS RX 11/02/2018
N209022 FLUTICASONE PROPIONATE XHANCE SPRAY, METERED NASAL 0.093MG 10076615 07/30/2029 U-2133 RX 10/12/2018
N022103 TROSPIUM CHLORIDE SANCTURA XR CAPSULE, EXTENDED RELEASE ORAL 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** 7759359 11/04/2024 U-1071 Y DISCN
N202834 PERAMPANEL FYCOMPA TABLET ORAL 4MG 6949571 06/08/2021 DS DP U-2428 RX 11/19/2012
N208276 TREPROSTINIL REMODULIN SOLUTION INTRAVENOUS, SUBCUTANEOUS 100MG/20ML (5MG/ML) 10076505 12/16/2024 DP RX 11/02/2018
N203634 BUDESONIDE UCERIS TABLET, EXTENDED RELEASE ORAL 9MG 10105374 06/09/2020 DP U-1325 RX 11/09/2018
N209863 TESTOSTERONE ENANTHATE XYOSTED (AUTOINJECTOR) SOLUTION SUBCUTANEOUS 100MG/0.5ML (100MG/0.5ML) 9180259 01/24/2026 DP DISCN 10/24/2018
N209863 TESTOSTERONE ENANTHATE XYOSTED (AUTOINJECTOR) SOLUTION SUBCUTANEOUS 100MG/0.5ML (100MG/0.5ML) RE44847 08/10/2019 DP U-2419 DISCN 10/24/2018
N204569 SUVOREXANT BELSOMRA TABLET ORAL 20MG 10098892 05/29/2033 DP RX 10/17/2018
N207921 BECLOMETHASONE DIPROPIONATE QVAR REDIHALER AEROSOL, METERED INHALATION 0.04MG/INH 10086156 05/18/2031 DP RX 10/16/2018
N202192 RUXOLITINIB PHOSPHATE JAKAFI TABLET ORAL EQ 5MG BASE 9662335 12/12/2026 DS Y RX 06/29/2017
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 4MG BASE 9233115 08/12/2024 U-1778 RX 02/08/2016
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 4MG BASE 9175017 06/16/2029 U-1778 RX 12/14/2015
N202834 PERAMPANEL FYCOMPA TABLET ORAL 12MG 6949571 06/08/2021 DS DP U-2428 RX 11/19/2012
N207202 ARIPIPRAZOLE ABILIFY MYCITE KIT TABLET ORAL 5MG 10097388 09/19/2034 U-2169 RX 11/05/2018
N207202 ARIPIPRAZOLE ABILIFY MYCITE KIT TABLET ORAL 30MG 10097388 09/19/2034 U-2169 RX 11/05/2018
N209863 TESTOSTERONE ENANTHATE XYOSTED (AUTOINJECTOR) SOLUTION SUBCUTANEOUS 100MG/0.5ML (100MG/0.5ML) 8021335 10/04/2026 DP DISCN 10/24/2018
N209863 TESTOSTERONE ENANTHATE XYOSTED (AUTOINJECTOR) SOLUTION SUBCUTANEOUS 100MG/0.5ML (100MG/0.5ML) 8562564 01/24/2026 DP DISCN 10/24/2018
N211288 DACOMITINIB VIZIMPRO TABLET ORAL 30MG 7772243 08/26/2028 DS DP RX 10/25/2018
N202880 HYDROCODONE BITARTRATE ZOHYDRO ER CAPSULE, EXTENDED RELEASE ORAL 30MG 10092559 09/12/2034 U-55 RX 11/13/2018
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 280MG 10106548 06/03/2033 DS DP RX 10/26/2018
N209863 TESTOSTERONE ENANTHATE XYOSTED (AUTOINJECTOR) SOLUTION SUBCUTANEOUS 100MG/0.5ML (100MG/0.5ML) 9629959 01/24/2026 DP DISCN 10/24/2018
N211155 DUVELISIB COPIKTRA CAPSULE ORAL 15MG 9216982 01/05/2029 U-2412 RX 10/23/2018
N208277 PERAMPANEL FYCOMPA SUSPENSION ORAL 0.5MG/ML 6949571 06/08/2021 DS DP U-2429 RX 05/27/2016
N208277 PERAMPANEL FYCOMPA SUSPENSION ORAL 0.5MG/ML 8772497 07/01/2026 DS RX 05/27/2016
N202834 PERAMPANEL FYCOMPA TABLET ORAL 2MG 6949571 06/08/2021 DS DP U-2089 RX 11/19/2012
N209863 TESTOSTERONE ENANTHATE XYOSTED (AUTOINJECTOR) SOLUTION SUBCUTANEOUS 75MG/0.5ML (75MG/0.5ML) 9629959 01/24/2026 DP DISCN 10/24/2018
N209863 TESTOSTERONE ENANTHATE XYOSTED (AUTOINJECTOR) SOLUTION SUBCUTANEOUS 75MG/0.5ML (75MG/0.5ML) RE44846 08/10/2019 DP DISCN 10/24/2018
N202834 PERAMPANEL FYCOMPA TABLET ORAL 10MG 6949571 06/08/2021 DS DP U-2429 RX 11/19/2012
N208623 MIGALASTAT HYDROCHLORIDE GALAFOLD CAPSULE ORAL EQ 123MG BASE 10076514 03/15/2037 U-2371 RX 10/18/2018
N202192 RUXOLITINIB PHOSPHATE JAKAFI TABLET ORAL EQ 25MG BASE 9662335 12/12/2026 DS Y RX 06/29/2017
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 4MG BASE 7442830 08/06/2027 DS DP U-2434 RX 12/14/2015
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 4MG BASE 8871745 08/06/2027 U-1779 RX 12/14/2015
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 4MG BASE 8003819 08/06/2027 DS DP U-1780 RX 12/14/2015
N202834 PERAMPANEL FYCOMPA TABLET ORAL 4MG 6949571 06/08/2021 DS DP U-106 RX 11/19/2012
N202834 PERAMPANEL FYCOMPA TABLET ORAL 4MG 8772497 07/01/2026 DS RX 08/06/2014
N209863 TESTOSTERONE ENANTHATE XYOSTED (AUTOINJECTOR) SOLUTION SUBCUTANEOUS 100MG/0.5ML (100MG/0.5ML) 9533102 01/24/2026 DP DISCN 10/24/2018
N209863 TESTOSTERONE ENANTHATE XYOSTED (AUTOINJECTOR) SOLUTION SUBCUTANEOUS 100MG/0.5ML (100MG/0.5ML) 9950125 09/04/2036 DP U-2418 DISCN 10/24/2018
N022315 DEXAMETHASONE OZURDEX IMPLANT INTRAVITREAL 0.7MG 10076526 01/09/2023 DP RX 10/17/2018
N022103 TROSPIUM CHLORIDE SANCTURA XR CAPSULE, EXTENDED RELEASE ORAL 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** 7781449 11/04/2024 U-1071 Y DISCN
N202834 PERAMPANEL FYCOMPA TABLET ORAL 4MG 6949571 06/08/2021 DS DP U-2429 RX 11/19/2012
N202834 PERAMPANEL FYCOMPA TABLET ORAL 12MG 6949571 06/08/2021 DS DP U-2088 RX 11/19/2012
N210491 IVACAFTOR; IVACAFTOR, TEZACAFTOR SYMDEKO (COPACKAGED) TABLET, TABLET ORAL 150MG,N/A;150MG, 100MG 10081621 03/25/2031 DP U-2420 RX 10/25/2018
N208276 TREPROSTINIL REMODULIN SOLUTION INTRAVENOUS, SUBCUTANEOUS 100MG/20ML (5MG/ML) 9604901 12/15/2028 DS RX 11/02/2018
N211155 DUVELISIB COPIKTRA CAPSULE ORAL 15MG 9840505 01/10/2032 U-2412 RX 10/23/2018
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 3MG BASE 8530694 08/06/2027 DS DP U-2434 RX 12/14/2015
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 3MG BASE 8003819 08/06/2027 DS DP U-1780 RX 12/14/2015
N202834 PERAMPANEL FYCOMPA TABLET ORAL 10MG 6949571 06/08/2021 DS DP U-2088 RX 11/19/2012
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 4MG BASE 8003819 08/06/2027 DS DP U-2434 RX 12/14/2015
N202834 PERAMPANEL FYCOMPA TABLET ORAL 4MG 6949571 06/08/2021 DS DP U-2088 RX 11/19/2012
N202834 PERAMPANEL FYCOMPA TABLET ORAL 12MG 6949571 06/08/2021 DS DP U-2429 RX 11/19/2012
N203567 EFINACONAZOLE JUBLIA SOLUTION TOPICAL 10% 10105444 07/08/2030 DP RX 10/24/2018
N202192 RUXOLITINIB PHOSPHATE JAKAFI TABLET ORAL EQ 15MG BASE 9662335 12/12/2026 DS Y RX 06/29/2017
N211155 DUVELISIB COPIKTRA CAPSULE ORAL 15MG 9216982 01/05/2029 U-2413 RX 10/23/2018
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 3MG BASE 8871745 08/06/2027 U-2434 RX 12/14/2015
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 3MG BASE 9233115 08/12/2024 U-2434 RX 02/08/2016
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 3MG BASE 7442830 08/06/2027 DS DP U-1780 RX 12/14/2015
N202880 HYDROCODONE BITARTRATE ZOHYDRO ER CAPSULE, EXTENDED RELEASE ORAL 15MG 10092559 09/12/2034 U-55 RX 11/13/2018
N210045 AMLODIPINE BESYLATE; CELECOXIB CONSENSI TABLET ORAL EQ 5MG BASE;200MG 9662315 02/28/2030 DP U-2410 RX 10/16/2018
N208276 TREPROSTINIL REMODULIN SOLUTION INTRAVENOUS, SUBCUTANEOUS 100MG/20ML (5MG/ML) 9593066 12/15/2028 DS RX 11/02/2018
N207921 BECLOMETHASONE DIPROPIONATE QVAR REDIHALER AEROSOL, METERED INHALATION 0.08MG/INH 10086156 05/18/2031 DP RX 10/16/2018
N211288 DACOMITINIB VIZIMPRO TABLET ORAL 30MG 8623883 05/05/2025 U-1403 RX 10/25/2018
N208341 SOFOSBUVIR; VELPATASVIR EPCLUSA TABLET ORAL 400MG;100MG 10086011 01/30/2034 U-1470 RX 10/23/2018
N020911 BECLOMETHASONE DIPROPIONATE QVAR 40 AEROSOL, METERED INHALATION 0.04MG/INH 10086156 05/18/2031 DP DISCN 10/16/2018
N208276 TREPROSTINIL REMODULIN SOLUTION INTRAVENOUS, SUBCUTANEOUS 200MG/20ML (10MG/ML) 9593066 12/15/2028 DS RX 10/01/2018
N022278 TRYPAN BLUE MEMBRANEBLUE SOLUTION OPHTHALMIC 0.15% 6372449 11/12/2019 U-2379 RX 09/06/2018
N208277 PERAMPANEL FYCOMPA SUSPENSION ORAL 0.5MG/ML 6949571 06/08/2021 DS DP U-2089 RX 05/27/2016
N202834 PERAMPANEL FYCOMPA TABLET ORAL 2MG 6949571 06/08/2021 DS DP U-2088 RX 11/19/2012
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 3MG BASE 9233115 08/12/2024 U-1778 RX 02/08/2016
N205552 IBRUTINIB IMBRUVICA CAPSULE ORAL 70MG 10106548 06/03/2033 DS DP RX 10/26/2018
N208276 TREPROSTINIL REMODULIN SOLUTION INTRAVENOUS, SUBCUTANEOUS 200MG/20ML (10MG/ML) 9713599 12/16/2024 U-2036 RX 10/01/2018
N209305 HYDROGEN PEROXIDE ESKATA SOLUTION TOPICAL 40% 10098910 04/21/2035 DP U-2205 RX 10/25/2018
N209863 TESTOSTERONE ENANTHATE XYOSTED (AUTOINJECTOR) SOLUTION SUBCUTANEOUS 50MG/0.5ML (50MG/0.5ML) RE44846 08/10/2019 DP DISCN 10/24/2018
N202834 PERAMPANEL FYCOMPA TABLET ORAL 2MG 6949571 06/08/2021 DS DP U-2429 RX 11/19/2012
N209863 TESTOSTERONE ENANTHATE XYOSTED (AUTOINJECTOR) SOLUTION SUBCUTANEOUS 75MG/0.5ML (75MG/0.5ML) 8021335 10/04/2026 DP DISCN 10/24/2018
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 8859619 12/22/2019 DP RX 10/28/2014
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 8457988 12/17/2022 U-1110 RX 07/02/2013
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 8731963 12/17/2022 U-1110 RX 05/30/2014
N211155 DUVELISIB COPIKTRA CAPSULE ORAL 15MG RE46621 05/17/2032 DS DP RX 10/23/2018
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 3MG BASE 8003819 08/06/2027 DS DP U-2434 RX 12/14/2015
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 3MG BASE 8871745 08/06/2027 U-1779 RX 12/14/2015
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 3MG BASE 7442830 08/06/2027 DS DP U-2434 RX 12/14/2015
N202450 ACLIDINIUM BROMIDE TUDORZA PRESSAIR POWDER, METERED INHALATION 0.4MG/INH 10034867 07/07/2020 DP U-2431 RX 10/25/2018
N208277 PERAMPANEL FYCOMPA SUSPENSION ORAL 0.5MG/ML 6949571 06/08/2021 DS DP U-2428 RX 05/27/2016
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 140MG 10106548 06/03/2033 DS DP RX 10/26/2018
N209863 TESTOSTERONE ENANTHATE XYOSTED (AUTOINJECTOR) SOLUTION SUBCUTANEOUS 75MG/0.5ML (75MG/0.5ML) 9744302 11/19/2035 DP DISCN 10/24/2018
N209863 TESTOSTERONE ENANTHATE XYOSTED (AUTOINJECTOR) SOLUTION SUBCUTANEOUS 75MG/0.5ML (75MG/0.5ML) 9950125 09/04/2036 DP U-2418 DISCN 10/24/2018
N209863 TESTOSTERONE ENANTHATE XYOSTED (AUTOINJECTOR) SOLUTION SUBCUTANEOUS 75MG/0.5ML (75MG/0.5ML) RE44847 08/10/2019 DP U-2419 DISCN 10/24/2018
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 8952062 12/22/2019 U-1102 RX 02/19/2015
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 6780889 07/04/2020 DP RX
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 7668730 06/16/2024 U-1110 RX
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 8589182 12/17/2022 U-1110 RX
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 7765106*PED 12/16/2024 RX
N211288 DACOMITINIB VIZIMPRO TABLET ORAL 15MG 7772243 08/26/2028 DS DP RX 10/25/2018
N202834 PERAMPANEL FYCOMPA TABLET ORAL 8MG 6949571 06/08/2021 DS DP U-2089 RX 11/19/2012
N202834 PERAMPANEL FYCOMPA TABLET ORAL 8MG 8772497 07/01/2026 DS RX 08/06/2014
N206099 SUMATRIPTAN SUCCINATE ONZETRA XSAIL POWDER INHALATION EQ 11MG BASE 10076615 07/30/2029 U-2011 RX 10/12/2018
N209863 TESTOSTERONE ENANTHATE XYOSTED (AUTOINJECTOR) SOLUTION SUBCUTANEOUS 50MG/0.5ML (50MG/0.5ML) 8021335 10/04/2026 DP DISCN 10/24/2018
N209863 TESTOSTERONE ENANTHATE XYOSTED (AUTOINJECTOR) SOLUTION SUBCUTANEOUS 50MG/0.5ML (50MG/0.5ML) 8562564 01/24/2026 DP DISCN 10/24/2018
N020911 BECLOMETHASONE DIPROPIONATE QVAR 80 AEROSOL, METERED INHALATION 0.08MG/INH 10086156 05/18/2031 DP DISCN 10/16/2018
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 9050302*PED 09/15/2033 RX
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 8772306 03/15/2033 U-1532 RX 07/09/2014
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 9539330 12/22/2019 DP RX 02/08/2017
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 7895059 12/17/2022 U-1110 RX
N202450 ACLIDINIUM BROMIDE TUDORZA PRESSAIR POWDER, METERED INHALATION 0.4MG/INH 10034867 07/07/2020 DP U-2432 RX 10/25/2018
N207202 ARIPIPRAZOLE ABILIFY MYCITE KIT TABLET ORAL 15MG 10097388 09/19/2034 U-2169 RX 11/05/2018
N202834 PERAMPANEL FYCOMPA TABLET ORAL 8MG 6949571 06/08/2021 DS DP U-2429 RX 11/19/2012
N209863 TESTOSTERONE ENANTHATE XYOSTED (AUTOINJECTOR) SOLUTION SUBCUTANEOUS 50MG/0.5ML (50MG/0.5ML) 9533102 01/24/2026 DP DISCN 10/24/2018
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 8324275 12/22/2019 U-1101 RX 12/05/2012
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 3MG BASE 9175017 06/16/2029 U-2434 RX 12/14/2015
N205832 NINTEDANIB ESYLATE OFEV CAPSULE ORAL EQ 100MG BASE 10105323 06/04/2029 DP RX 11/06/2018
N208276 TREPROSTINIL REMODULIN SOLUTION INTRAVENOUS, SUBCUTANEOUS 200MG/20ML (10MG/ML) 10076505 12/16/2024 DP RX 10/01/2018
N209863 TESTOSTERONE ENANTHATE XYOSTED (AUTOINJECTOR) SOLUTION SUBCUTANEOUS 75MG/0.5ML (75MG/0.5ML) 9180259 01/24/2026 DP DISCN 10/24/2018
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 8952062*PED 06/22/2020 RX
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 8859619*PED 06/22/2020 RX
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 8324275 12/22/2019 U-1102 RX 12/05/2012
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 9050302 03/15/2033 U-1532 RX 07/08/2015
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 8952062 12/22/2019 U-1101 RX 02/19/2015
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 7765106 06/16/2024 U-1069 RX
N204569 SUVOREXANT BELSOMRA TABLET ORAL 5MG 10098892 05/29/2033 DP RX 10/17/2018
N211155 DUVELISIB COPIKTRA CAPSULE ORAL 15MG 8193182 02/13/2030 DS RX 10/23/2018
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 3MG BASE 8530694 08/06/2027 DS DP U-1780 RX 12/14/2015
N202880 HYDROCODONE BITARTRATE ZOHYDRO ER CAPSULE, EXTENDED RELEASE ORAL 50MG 10092559 09/12/2034 U-55 RX 11/13/2018
N202450 ACLIDINIUM BROMIDE TUDORZA PRESSAIR POWDER, METERED INHALATION 0.4MG/INH 10085974 03/13/2029 DP U-1263 RX 10/26/2018
N204569 SUVOREXANT BELSOMRA TABLET ORAL 15MG 10098892 05/29/2033 DP RX 10/17/2018
N208276 TREPROSTINIL REMODULIN SOLUTION INTRAVENOUS, SUBCUTANEOUS 200MG/20ML (10MG/ML) 9604901 12/15/2028 DS RX 10/01/2018
N202880 HYDROCODONE BITARTRATE ZOHYDRO ER CAPSULE, EXTENDED RELEASE ORAL 20MG 10092559 09/12/2034 U-55 RX 11/13/2018
N202834 PERAMPANEL FYCOMPA TABLET ORAL 8MG 6949571 06/08/2021 DS DP U-106 RX 11/19/2012
N204569 SUVOREXANT BELSOMRA TABLET ORAL 10MG 10098892 05/29/2033 DP RX 10/17/2018
N211155 DUVELISIB COPIKTRA CAPSULE ORAL 15MG 9840505 01/10/2032 U-2413 RX 10/23/2018
N206038 IVACAFTOR; LUMACAFTOR ORKAMBI TABLET ORAL 125MG;200MG 10076513 12/04/2028 DP U-2411 RX 10/18/2018
N202192 RUXOLITINIB PHOSPHATE JAKAFI TABLET ORAL EQ 20MG BASE 9662335 12/12/2026 DS Y RX 06/29/2017
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 3MG BASE 9175017 06/16/2029 U-1778 RX 12/14/2015
N210951 APALUTAMIDE ERLEADA TABLET ORAL 60MG 9987261 03/27/2027 DP RX 10/18/2018
N206099 SUMATRIPTAN SUCCINATE ONZETRA XSAIL POWDER INHALATION EQ 11MG BASE 10076615 07/30/2029 U-2010 RX 10/12/2018
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 560MG 10106548 06/03/2033 DS DP RX 10/26/2018
N209863 TESTOSTERONE ENANTHATE XYOSTED (AUTOINJECTOR) SOLUTION SUBCUTANEOUS 50MG/0.5ML (50MG/0.5ML) 9950125 09/04/2036 DP U-2418 DISCN 10/24/2018
N203168 BROMFENAC SODIUM PROLENSA SOLUTION/DROPS OPHTHALMIC EQ 0.07% ACID 10085958 11/19/2032 DP RX 10/15/2018
N209863 TESTOSTERONE ENANTHATE XYOSTED (AUTOINJECTOR) SOLUTION SUBCUTANEOUS 75MG/0.5ML (75MG/0.5ML) 9533102 01/24/2026 DP DISCN 10/24/2018
N202834 PERAMPANEL FYCOMPA TABLET ORAL 8MG 6949571 06/08/2021 DS DP U-2088 RX 11/19/2012
N210045 AMLODIPINE BESYLATE; CELECOXIB CONSENSI TABLET ORAL EQ 10MG BASE;200MG 9662315 02/28/2030 DP U-2410 RX 10/16/2018
N209863 TESTOSTERONE ENANTHATE XYOSTED (AUTOINJECTOR) SOLUTION SUBCUTANEOUS 50MG/0.5ML (50MG/0.5ML) 9744302 11/19/2035 DP DISCN 10/24/2018
N022278 TRYPAN BLUE MEMBRANEBLUE SOLUTION OPHTHALMIC 0.15% 6696430 05/07/2019 U-2377 RX 09/06/2018
N208277 PERAMPANEL FYCOMPA SUSPENSION ORAL 0.5MG/ML 6949571 06/08/2021 DS DP U-2088 RX 05/27/2016
N207202 ARIPIPRAZOLE ABILIFY MYCITE KIT TABLET ORAL 2MG 10097388 09/19/2034 U-2169 RX 11/05/2018
N202834 PERAMPANEL FYCOMPA TABLET ORAL 2MG 6949571 06/08/2021 DS DP U-106 RX 11/19/2012
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 9539330*PED 06/22/2020 RX
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 7765107 06/16/2024 U-1070 RX
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 7851506 12/22/2019 U-1101 RX
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 8772306*PED 09/15/2033 RX
N202834 PERAMPANEL FYCOMPA TABLET ORAL 8MG 6949571 06/08/2021 DS DP U-2428 RX 11/19/2012
N206099 SUMATRIPTAN SUCCINATE ONZETRA XSAIL POWDER INHALATION EQ 11MG BASE 10076615 07/30/2029 U-2404 RX 10/12/2018
N209863 TESTOSTERONE ENANTHATE XYOSTED (AUTOINJECTOR) SOLUTION SUBCUTANEOUS 50MG/0.5ML (50MG/0.5ML) 9180259 01/24/2026 DP DISCN 10/24/2018
N209863 TESTOSTERONE ENANTHATE XYOSTED (AUTOINJECTOR) SOLUTION SUBCUTANEOUS 50MG/0.5ML (50MG/0.5ML) 9629959 01/24/2026 DP DISCN 10/24/2018
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 2.3MG BASE 9175017 06/16/2029 U-2434 RX 12/14/2015
N202834 PERAMPANEL FYCOMPA TABLET ORAL 6MG 6949571 06/08/2021 DS DP U-2088 RX 11/19/2012
N207356 AMIKACIN SULFATE ARIKAYCE KIT SUSPENSION, LIPOSOMAL INHALATION EQ 590MG BASE/8.4ML 7718189 06/06/2025 DP U-2415 RX 10/24/2018
N207356 AMIKACIN SULFATE ARIKAYCE KIT SUSPENSION, LIPOSOMAL INHALATION EQ 590MG BASE/8.4ML 9827317 04/08/2024 DP U-2415 RX 10/24/2018
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 8263650 12/22/2019 DP U-1101 RX 09/20/2012
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 9486426 03/15/2033 U-1532 RX 12/06/2016
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 7851506 12/22/2019 U-1102 RX
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 7262219*PED 01/04/2021 RX
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 8263650*PED 06/22/2020 RX
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 2.3MG BASE 8871745 08/06/2027 U-1779 RX 12/14/2015
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 2.3MG BASE 8530694 08/06/2027 DS DP U-1780 RX 12/14/2015
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 2.3MG BASE 7442830 08/06/2027 DS DP U-2434 RX 12/14/2015
N202880 HYDROCODONE BITARTRATE ZOHYDRO ER CAPSULE, EXTENDED RELEASE ORAL 40MG 10092559 09/12/2034 U-55 RX 11/13/2018
N205552 IBRUTINIB IMBRUVICA CAPSULE ORAL 140MG 10106548 06/03/2033 DS DP RX 10/26/2018
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 8263650 12/22/2019 DP U-1102 RX 09/20/2012
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 7765107*PED 12/16/2024 RX
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 7668730*PED 12/16/2024 RX
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 2.3MG BASE 8003819 08/06/2027 DS DP U-2434 RX 12/14/2015
N020772 SACROSIDASE SUCRAID SOLUTION ORAL 8,500 IU/ML 9255261 02/07/2034 DS DP RX 10/26/2018
N202834 PERAMPANEL FYCOMPA TABLET ORAL 6MG 8772497 07/01/2026 DS RX 08/06/2014
N211155 DUVELISIB COPIKTRA CAPSULE ORAL 25MG RE46621 05/17/2032 DS DP RX 10/23/2018
N207356 AMIKACIN SULFATE ARIKAYCE KIT SUSPENSION, LIPOSOMAL INHALATION EQ 590MG BASE/8.4ML 8802137 04/08/2024 DP U-2414 RX 10/24/2018
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 7851506*PED 06/22/2020 RX
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 6780889*PED 01/04/2021 RX
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 8457988*PED 06/17/2023 RX
N211288 DACOMITINIB VIZIMPRO TABLET ORAL 15MG 8623883 05/05/2025 U-1403 RX 10/25/2018
N202834 PERAMPANEL FYCOMPA TABLET ORAL 6MG 6949571 06/08/2021 DS DP U-106 RX 11/19/2012
N202834 PERAMPANEL FYCOMPA TABLET ORAL 6MG 6949571 06/08/2021 DS DP U-2429 RX 11/19/2012
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 420MG 10106548 06/03/2033 DS DP RX 10/26/2018
N207356 AMIKACIN SULFATE ARIKAYCE KIT SUSPENSION, LIPOSOMAL INHALATION EQ 590MG BASE/8.4ML 9566234 01/18/2034 DP U-2415 RX 10/24/2018
N021782 RAMELTEON ROZEREM TABLET ORAL 8MG 10098866 11/16/2021 DP U-2433 RX 11/06/2018
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 2.3MG BASE 8871745 08/06/2027 U-2434 RX 12/14/2015
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 2.3MG BASE 9233115 08/12/2024 U-2434 RX 02/08/2016
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 2.3MG BASE 8530694 08/06/2027 DS DP U-2434 RX 12/14/2015
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 2.3MG BASE 9175017 06/16/2029 U-1778 RX 12/14/2015
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 2.3MG BASE 7442830 08/06/2027 DS DP U-1780 RX 12/14/2015
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 2.3MG BASE 8003819 08/06/2027 DS DP U-1780 RX 12/14/2015
N211155 DUVELISIB COPIKTRA CAPSULE ORAL 25MG 9840505 01/10/2032 U-2412 RX 10/23/2018
N207356 AMIKACIN SULFATE ARIKAYCE KIT SUSPENSION, LIPOSOMAL INHALATION EQ 590MG BASE/8.4ML 8679532 12/05/2026 U-2415 RX 10/24/2018
N202834 PERAMPANEL FYCOMPA TABLET ORAL 6MG 6949571 06/08/2021 DS DP U-2089 RX 11/19/2012
N211155 DUVELISIB COPIKTRA CAPSULE ORAL 25MG 9216982 01/05/2029 U-2413 RX 10/23/2018
N207356 AMIKACIN SULFATE ARIKAYCE KIT SUSPENSION, LIPOSOMAL INHALATION EQ 590MG BASE/8.4ML 8226975 08/15/2028 DP RX 10/24/2018
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 7895059*PED 06/17/2023 RX
N211155 DUVELISIB COPIKTRA CAPSULE ORAL 25MG 9840505 01/10/2032 U-2413 RX 10/23/2018
N211155 DUVELISIB COPIKTRA CAPSULE ORAL 25MG 8193182 02/13/2030 DS RX 10/23/2018
N207356 AMIKACIN SULFATE ARIKAYCE KIT SUSPENSION, LIPOSOMAL INHALATION EQ 590MG BASE/8.4ML 8642075 12/05/2026 DP RX 10/24/2018
N209606 ENASIDENIB MESYLATE IDHIFA TABLET ORAL EQ 100MG BASE 10093654 08/01/2034 DS DP U-2087 RX 11/07/2018
N208277 PERAMPANEL FYCOMPA SUSPENSION ORAL 0.5MG/ML 6949571 06/08/2021 DS DP U-106 RX 05/27/2016
N202834 PERAMPANEL FYCOMPA TABLET ORAL 2MG 6949571 06/08/2021 DS DP U-2428 RX 11/19/2012
N202834 PERAMPANEL FYCOMPA TABLET ORAL 2MG 8772497 07/01/2026 DS RX 08/06/2014
N209863 TESTOSTERONE ENANTHATE XYOSTED (AUTOINJECTOR) SOLUTION SUBCUTANEOUS 75MG/0.5ML (75MG/0.5ML) 8562564 01/24/2026 DP DISCN 10/24/2018
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 9486426*PED 09/15/2033 RX
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 7262219 07/04/2020 DP RX
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 8589182*PED 06/17/2023 RX
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 8324275*PED 06/22/2020 RX
N020772 SACROSIDASE SUCRAID SOLUTION ORAL 8,500 IU/ML 9849161 02/07/2034 DS DP RX 10/26/2018
N207202 ARIPIPRAZOLE ABILIFY MYCITE KIT TABLET ORAL 10MG 10097388 09/19/2034 U-2169 RX 11/05/2018
N211155 DUVELISIB COPIKTRA CAPSULE ORAL 25MG 9216982 01/05/2029 U-2412 RX 10/23/2018
N211288 DACOMITINIB VIZIMPRO TABLET ORAL 45MG 8623883 05/05/2025 U-1403 RX 10/25/2018
N021196 SODIUM OXYBATE XYREM SOLUTION ORAL 500MG/ML 8731963*PED 06/17/2023 RX
N021457 ALBUTEROL SULFATE PROAIR HFA AEROSOL, METERED INHALATION EQ 0.09MG BASE/INH 10086156 05/18/2031 DP RX 10/17/2018
N206099 SUMATRIPTAN SUCCINATE ONZETRA XSAIL POWDER INHALATION EQ 11MG BASE 10076614 10/20/2034 DP RX 10/12/2018
N209863 TESTOSTERONE ENANTHATE XYOSTED (AUTOINJECTOR) SOLUTION SUBCUTANEOUS 50MG/0.5ML (50MG/0.5ML) RE44847 08/10/2019 DP U-2419 DISCN 10/24/2018
N208462 IXAZOMIB CITRATE NINLARO CAPSULE ORAL EQ 2.3MG BASE 9233115 08/12/2024 U-1778 RX 02/08/2016
N202834 PERAMPANEL FYCOMPA TABLET ORAL 6MG 6949571 06/08/2021 DS DP U-2428 RX 11/19/2012
N211288 DACOMITINIB VIZIMPRO TABLET ORAL 45MG 7772243 08/26/2028 DS DP RX 10/25/2018
N207356 AMIKACIN SULFATE ARIKAYCE KIT SUSPENSION, LIPOSOMAL INHALATION EQ 590MG BASE/8.4ML 9895385 05/15/2035 U-2417 RX 10/24/2018
N207356 AMIKACIN SULFATE ARIKAYCE KIT SUSPENSION, LIPOSOMAL INHALATION EQ 590MG BASE/8.4ML 8632804 12/05/2026 U-2416 RX 10/24/2018

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Last Updated November 14, 2018.

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