Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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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