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.
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
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 7456254 06/30/2025 DP
U-2592 IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
RX 11/03/2017
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 6872700 01/14/2020
U-2589 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
RX 11/03/2017
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 8895033 10/04/2030 DP
U-2600 IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A PRE-MIXED EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
RX 11/03/2017
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 7456254 06/30/2025 DP
U-2590 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
RX 11/03/2017
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 6872700 01/14/2020
U-2591 LOWERING PLASMA GLUCAGON IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING EXENATIDE AS AN ADJUNCT TO DIET AND EXERCISE
RX 11/03/2017
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 8895033 10/04/2030 DP
U-2597 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AS ADD-ON TO METFORMIN
RX 11/03/2017
N021717 LIDOCAINE; TETRACAINE PLIAGLIS CREAM TOPICAL 7%;7% 10350180 01/14/2031 DP
RX 11/04/2019
N205552 IBRUTINIB IMBRUVICA CAPSULE ORAL 70MG 10478439 06/03/2031
U-2242 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
RX 12/10/2019
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 7456254 06/30/2025 DP
U-2588 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
RX 11/03/2017
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 9238076 04/15/2024 DP
U-2599 IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE TO PROVIDE A RELEASE PROFILE HAVING A RATIO OF C-MAX TO C-AVG OF ABOUT 3 OR LESS
RX 11/03/2017
N211855 DIROXIMEL FUMARATE VUMERITY CAPSULE, DELAYED RELEASE ORAL 231MG 8669281 09/20/2033 DS DP
RX 11/22/2019
N205552 IBRUTINIB IMBRUVICA CAPSULE ORAL 70MG 10478439 06/03/2031
U-1456 TREATMENT OF MANTLE CELL LYMPHOMA
RX 12/10/2019
N205552 IBRUTINIB IMBRUVICA CAPSULE ORAL 70MG 10478439 06/03/2031
U-1684 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
RX 12/10/2019
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 8895033 10/04/2030 DP
U-2601 STIMULATING INSULIN RELEASE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A PRE-MIXED EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
RX 11/03/2017
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 9884092 08/18/2026
U-2597 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AS ADD-ON TO METFORMIN
RX 03/06/2018
N208564 ESTRADIOL IMVEXXY INSERT VAGINAL 0.01MG 10471072 06/18/2033
U-2317 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
RX 12/06/2019
N211855 DIROXIMEL FUMARATE VUMERITY CAPSULE, DELAYED RELEASE ORAL 231MG 9090558 09/20/2033
U-1384 METHOD OF TREATING MULTIPLE SCLEROSIS
RX 11/22/2019
N021945 HYDROXYPROGESTERONE CAPROATE MAKENA (AUTOINJECTOR) SOLUTION SUBCUTANEOUS 275MG/1.1ML (250MG/ML) 10471075 05/02/2036
U-2236 REDUCING THE RISK OF PRETERM BIRTH IN WOMEN WITH A SINGLETON PREGNANCY WHO HAVE A HISTORY OF SINGLETON SPONTANEOUS PRETERM BIRTH
RX 11/18/2019
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 8895033 10/04/2030 DP
U-2589 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
RX 11/03/2017
N208564 ESTRADIOL IMVEXXY INSERT VAGINAL 0.01MG 10471072 06/18/2033
U-2316 TREATMENT OF DYSPAREUNIA
RX 12/06/2019
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 9884092 08/18/2026
U-2596 REDUCING HBA1C IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
RX 03/06/2018
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 9884092 08/18/2026
U-2590 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
RX 03/06/2018
N205552 IBRUTINIB IMBRUVICA CAPSULE ORAL 70MG 10478439 06/03/2031
U-2241 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
RX 12/10/2019
N205552 IBRUTINIB IMBRUVICA CAPSULE ORAL 70MG 10478439 06/03/2031
U-1946 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
RX 12/10/2019
N205552 IBRUTINIB IMBRUVICA CAPSULE ORAL 70MG 10478439 06/03/2031
U-1947 TREATMENT OF MARGINAL ZONE LYMPHOMA
RX 12/10/2019
N205552 IBRUTINIB IMBRUVICA CAPSULE ORAL 70MG 10463668 10/24/2034
U-2654 TREATMENT OF REFRACTORY CHRONIC GRAFT-VERSUS-HOST DISEASE
RX 11/20/2019
N205831 METHYLPHENIDATE HYDROCHLORIDE APTENSIO XR CAPSULE, EXTENDED RELEASE ORAL 15MG 10463624 12/16/2019 DP
RX 11/26/2019
N211855 DIROXIMEL FUMARATE VUMERITY CAPSULE, DELAYED RELEASE ORAL 231MG 10080733 09/20/2033 DS DP
U-1384 METHOD OF TREATING MULTIPLE SCLEROSIS
RX 11/22/2019
N205552 IBRUTINIB IMBRUVICA CAPSULE ORAL 70MG 10478439 06/03/2031
U-1650 TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
RX 12/10/2019
N205552 IBRUTINIB IMBRUVICA CAPSULE ORAL 70MG 10478439 06/03/2031
U-2665 TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
RX 12/10/2019
N208910 VANCOMYCIN HYDROCHLORIDE FIRVANQ KIT FOR SOLUTION ORAL EQ 25MG BASE/ML 10493028 03/13/2035 DP
RX 12/05/2019
N205831 METHYLPHENIDATE HYDROCHLORIDE APTENSIO XR CAPSULE, EXTENDED RELEASE ORAL 60MG 10463624 12/16/2019 DP
RX 11/26/2019
N205436 TEDIZOLID PHOSPHATE SIVEXTRO POWDER INTRAVENOUS 200MG/VIAL 10442829 02/03/2030 DS
RX 11/13/2019
N207793 IRINOTECAN HYDROCHLORIDE ONIVYDE INJECTABLE, LIPOSOMAL INTRAVENOUS EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) 10456360 10/15/2036 DP
RX 11/25/2019
N212477 LEDIPASVIR; SOFOSBUVIR HARVONI PELLETS ORAL 33.75MG;150MG/PACKET 10456414 09/14/2032 DP
RX 11/20/2019
N205834 LEDIPASVIR; SOFOSBUVIR HARVONI TABLET ORAL 45MG;200MG 10456414 09/14/2032 DP
RX 11/20/2019
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 8431685 04/13/2025 DP
U-2590 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
RX 11/03/2017
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 9884092 08/18/2026
U-2593 IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
RX 03/06/2018
N020800 EPINEPHRINE ADRENACLICK INJECTABLE INTRAMUSCULAR, SUBCUTANEOUS EQ 0.3MG/DELIVERY 10166344 01/21/2025 DP
RX 11/15/2019
N205677 TASIMELTEON HETLIOZ CAPSULE ORAL 20MG 10449176 01/25/2033
U-2149 TREATMENT OF NON-24 HOUR SLEEP-WAKE DISORDER BY ADMINISTERING TASIMELTEON
RX 11/20/2019
N022535 PIRFENIDONE ESBRIET CAPSULE ORAL 267MG 8383150 09/22/2026 DP
U-2361 METHOD OF ADMINISTERING A GRANULATE FORMULATION OF 5-METHYL-1-PHENYL-2-(1H)-PYRIDONE AS RECITED IN CLAIM 1, TO TREAT IDIOPATHIC PULMONARY FIBROSIS
RX 11/14/2014
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 7456254 06/30/2025 DP
U-2589 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
RX 11/03/2017
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 9238076 04/15/2024 DP
U-2590 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
RX 11/03/2017
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 8906851 08/18/2026
U-2593 IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
RX 11/03/2017
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 9238076 04/15/2024 DP
U-2597 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AS ADD-ON TO METFORMIN
RX 11/03/2017
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 8461105 04/13/2025 DP
U-2598 IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN INJECTABLE SUSTAINED RELEASE FORMULATION OF EXENATIDE AS AN ADJUNCT TO DIET AND EXERCISE
RX 11/03/2017
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 8431685 04/13/2025 DP
U-2598 IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN INJECTABLE SUSTAINED RELEASE FORMULATION OF EXENATIDE AS AN ADJUNCT TO DIET AND EXERCISE
RX 11/03/2017
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 8906851 08/18/2026
U-2597 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AS ADD-ON TO METFORMIN
RX 11/03/2017
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 8431685 04/13/2025 DP
U-2589 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
RX 11/03/2017
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 8329648 08/18/2026
U-2596 REDUCING HBA1C IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
RX 11/03/2017
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 9238076 04/15/2024 DP
U-2589 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
RX 11/03/2017
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 8906851 08/18/2026
U-2589 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
RX 11/03/2017
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 8329648 08/18/2026
U-2595 REDUCING BODY WEIGHT IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
RX 11/03/2017
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 6872700 01/14/2020
U-2590 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
RX 11/03/2017
N205437 APREMILAST OTEZLA TABLET ORAL 10MG 9018243 03/19/2023
U-1505 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
RX 05/18/2015
N205437 APREMILAST OTEZLA TABLET ORAL 10MG 9724330 03/19/2023
U-2658 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE
RX 07/19/2018
N205437 APREMILAST OTEZLA TABLET ORAL 10MG 7659302 03/19/2023
U-2657 TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
RX 04/15/2014
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 8329648 08/18/2026
U-2588 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AND METFORMIN
RX 11/03/2017
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 8906851 08/18/2026
U-2590 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
RX 11/03/2017
N205834 LEDIPASVIR; SOFOSBUVIR HARVONI TABLET ORAL 90MG;400MG 10456414 09/14/2032 DP
RX 11/20/2019
N022563 CALCIPOTRIENE SORILUX AEROSOL, FOAM TOPICAL 0.005% 8629128 05/26/2026 DP
U-2662 USE OF CALCIPOTRIENE FOAM FOR THE TOPICAL TREATMENT OF PLAQUE PSORIASIS IN PATIENTS AGED 4 YEARS AND OLDER
RX 04/17/2014
N208447 NIRAPARIB TOSYLATE ZEJULA CAPSULE ORAL EQ 100MG BASE 8071579 08/12/2027
U-2655 A METHOD OF TREATMENT OF ADVANCED OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER ASSOCIATED WITH HOMOLOGOUS RECOMBINATION DEFICIENCY (HRD) POSITIVE STATUS
RX 11/22/2019
N205437 APREMILAST OTEZLA TABLET ORAL 30MG 9018243 03/19/2023
U-1595 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
RX 05/18/2015
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 7612176 04/13/2025 DP
U-2590 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
RX 11/03/2017
N205437 APREMILAST OTEZLA TABLET ORAL 10MG 8455536 03/19/2023
U-1595 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
RX 04/15/2014
N205437 APREMILAST OTEZLA TABLET ORAL 10MG 8455536 03/19/2023
U-1505 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
RX 04/15/2014
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 9884092 08/18/2026
U-2589 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
RX 03/06/2018
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 8461105 04/13/2025 DP
U-2597 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AS ADD-ON TO METFORMIN
RX 11/03/2017
N205435 TEDIZOLID PHOSPHATE SIVEXTRO TABLET ORAL 200MG 10442829 02/03/2030 DS
RX 11/13/2019
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 9884092 08/18/2026
U-2595 REDUCING BODY WEIGHT IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
RX 03/06/2018
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 8895033 10/04/2030 DP
U-2590 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
RX 11/03/2017
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 8329648 08/18/2026
U-2590 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
RX 11/03/2017
N205831 METHYLPHENIDATE HYDROCHLORIDE APTENSIO XR CAPSULE, EXTENDED RELEASE ORAL 40MG 10463624 12/16/2019 DP
RX 11/26/2019
N212379 MINOCYCLINE HYDROCHLORIDE AMZEEQ AEROSOL, FOAM TOPICAL EQ 4% BASE 10398641 09/08/2037
U-2647 TREATMENT OF NON-NODULAR ACNE VULGARIS
RX 11/15/2019
N212379 MINOCYCLINE HYDROCHLORIDE AMZEEQ AEROSOL, FOAM TOPICAL EQ 4% BASE 9675700 10/01/2030 DP
U-2647 TREATMENT OF NON-NODULAR ACNE VULGARIS
RX 11/15/2019
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 8461105 04/13/2025 DP
U-2590 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH METFORMIN, A SULFONYLUREA, A THIAZOLIDINEDIONE, OR COMBINATION OF ANY TWO OF THESE THERAPIES
RX 11/03/2017
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 8431685 04/13/2025 DP
U-2597 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH DAPAGLIFLOZIN AS ADD-ON TO METFORMIN
RX 11/03/2017
N208623 MIGALASTAT HYDROCHLORIDE GALAFOLD CAPSULE ORAL EQ 123MG BASE 10471053 05/30/2038
U-2371 THE TREATMENT OF FABRY PATIENTS
RX 12/06/2019
N205437 APREMILAST OTEZLA TABLET ORAL 10MG 9724330 03/19/2023
U-2657 TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
RX 07/19/2018
N205437 APREMILAST OTEZLA TABLET ORAL 10MG 10092541 05/29/2034
U-2659 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE USING A DOSAGE TITRATION SCHEDULE
RX 10/09/2018
N205437 APREMILAST OTEZLA TABLET ORAL 10MG 7659302 03/19/2023
U-1505 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
RX 04/15/2014
N207589 BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE ENSTILAR AEROSOL, FOAM TOPICAL 0.064%;0.005% 9566286 06/10/2031 DP
RX 11/15/2019
N205437 APREMILAST OTEZLA TABLET ORAL 10MG 6962940 03/19/2023
U-2658 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE
RX 04/15/2014
N205831 METHYLPHENIDATE HYDROCHLORIDE APTENSIO XR CAPSULE, EXTENDED RELEASE ORAL 20MG 10463624 12/16/2019 DP
RX 11/26/2019
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 560MG 10478439 06/03/2031
U-1456 TREATMENT OF MANTLE CELL LYMPHOMA
RX 12/10/2019
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 560MG 10478439 06/03/2031
U-2241 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
RX 12/10/2019
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 560MG 10478439 06/03/2031
U-2665 TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
RX 12/10/2019
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 8895033 10/04/2030 DP
U-2602 DELAYING GASTRIC EMPTYING IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A PRE-MIXED EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
RX 11/03/2017
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 9884092 08/18/2026
U-2594 REDUCING FASTING PLASMA GLUCOSE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
RX 03/06/2018
N210913 CYCLOSPORINE CEQUA SOLUTION OPHTHALMIC 0.09% 10441630 08/23/2033 DP
RX 11/14/2019
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 560MG 10478439 06/03/2031
U-1947 TREATMENT OF MARGINAL ZONE LYMPHOMA
RX 12/10/2019
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 560MG 10478439 06/03/2031
U-2242 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
RX 12/10/2019
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 8461105 04/13/2025 DP
U-2589 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
RX 11/03/2017
N208215 EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE DESCOVY TABLET ORAL 200MG;EQ 25MG BASE 9296769 08/15/2032 DS DP
U-257 TREATMENT OF HIV INFECTION
RX 04/26/2016
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 7612176 04/13/2025 DP
U-2592 IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING A SUSTAINED-RELEASE EXENATIDE FORMULATION AS AN ADJUNCT TO DIET AND EXERCISE
RX 11/03/2017
N208215 EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE DESCOVY TABLET ORAL 200MG;EQ 25MG BASE 9296769 08/15/2032 DS DP
U-1259 PROPHYLAXIS OF HIV-1 INFECTION
RX 04/26/2016
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 560MG 10478439 06/03/2031
U-1650 TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
RX 12/10/2019
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 560MG 10478439 06/03/2031
U-1946 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
RX 12/10/2019
N022563 CALCIPOTRIENE SORILUX AEROSOL, FOAM TOPICAL 0.005% 8629128 05/26/2026 DP
U-1767 USE OF CALCIPOTRIENE FOAM FOR THE TOPICAL TREATMENT OF PLAQUE PSORIASIS IN PATIENTS AGED 18 YEARS AND OLDER
RX 04/17/2014
N022563 CALCIPOTRIENE SORILUX AEROSOL, FOAM TOPICAL 0.005% 8263580 05/07/2028 DP
U-1280 USE OF A CALCIPOTRIENE CONTAINING FOAM FOR THE TREATMENT OF PSORIASIS
RX 09/21/2012
N205437 APREMILAST OTEZLA TABLET ORAL 30MG 7659302 03/19/2023
U-1595 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
RX 04/15/2014
N205437 APREMILAST OTEZLA TABLET ORAL 30MG 9724330 03/19/2023
U-1595 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
RX 07/19/2018
N205437 APREMILAST OTEZLA TABLET ORAL 30MG 8455536 03/19/2023
U-2658 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE
RX 04/15/2014
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 8329648 08/18/2026
U-2589 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
RX 11/03/2017
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 560MG 10478439 06/03/2031
U-1684 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
RX 12/10/2019
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 7612176 04/13/2025 DP
U-2589 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS IN COMBINATION WITH BASAL INSULIN OR BASAL INSULIN PLUS METFORMIN
RX 11/03/2017
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 8329648 08/18/2026
U-2593 IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
RX 11/03/2017
N208215 EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE DESCOVY TABLET ORAL 200MG;EQ 25MG BASE 8754065 08/15/2032 DS DP
U-1259 PROPHYLAXIS OF HIV-1 INFECTION
RX 05/02/2016
N205437 APREMILAST OTEZLA TABLET ORAL 10MG 9724330 03/19/2023
U-1595 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
RX 07/19/2018
N205437 APREMILAST OTEZLA TABLET ORAL 10MG 9724330 03/19/2023
U-1561 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
RX 07/19/2018
N212379 MINOCYCLINE HYDROCHLORIDE AMZEEQ AEROSOL, FOAM TOPICAL EQ 4% BASE 8992896 10/01/2030 DP
U-2647 TREATMENT OF NON-NODULAR ACNE VULGARIS
RX 11/15/2019
N212379 MINOCYCLINE HYDROCHLORIDE AMZEEQ AEROSOL, FOAM TOPICAL EQ 4% BASE 10086080 10/01/2030
U-2647 TREATMENT OF NON-NODULAR ACNE VULGARIS
RX 11/15/2019
N022563 CALCIPOTRIENE SORILUX AEROSOL, FOAM TOPICAL 0.005% 8263580 05/07/2028 DP
U-2662 USE OF CALCIPOTRIENE FOAM FOR THE TOPICAL TREATMENT OF PLAQUE PSORIASIS IN PATIENTS AGED 4 YEARS AND OLDER
RX 09/21/2012
N205437 APREMILAST OTEZLA TABLET ORAL 30MG 9724330 03/19/2023
U-1561 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
RX 07/19/2018
N205437 APREMILAST OTEZLA TABLET ORAL 30MG 6962940 03/19/2023
U-1504 USE OF OTEZLA (APREMILAST) FOR INHIBITING PDE4
RX 04/15/2014
N205437 APREMILAST OTEZLA TABLET ORAL 10MG 6962940 03/19/2023
U-1504 USE OF OTEZLA (APREMILAST) FOR INHIBITING PDE4
RX 04/15/2014
N205437 APREMILAST OTEZLA TABLET ORAL 10MG 10092541 05/29/2034
U-2403 TREATMENT OF PSORIASIS USING A DOSAGE TITRATION SCHEDULE
RX 10/09/2018
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 280MG 10463668 10/24/2034
U-2654 TREATMENT OF REFRACTORY CHRONIC GRAFT-VERSUS-HOST DISEASE
RX 11/15/2019
N205437 APREMILAST OTEZLA TABLET ORAL 30MG 9018243 03/19/2023
U-1505 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
RX 05/18/2015
N205437 APREMILAST OTEZLA TABLET ORAL 30MG 7659302 03/19/2023
U-2657 TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
RX 04/15/2014
N206099 SUMATRIPTAN SUCCINATE ONZETRA XSAIL POWDER NASAL EQ 11MG BASE 10478574 11/04/2033
U-2404 METHOD OF DELIVERING SUMATRIPTAN TO A NASAL CAVITY
RX 12/09/2019
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 560MG 10463668 10/24/2034
U-2654 TREATMENT OF REFRACTORY CHRONIC GRAFT-VERSUS-HOST DISEASE
RX 11/15/2019
N203479 CLOZAPINE VERSACLOZ SUSPENSION ORAL 50MG/ML 8057811 05/01/2028 DP
RX 11/15/2019
N205437 APREMILAST OTEZLA TABLET ORAL 30MG 7659302 03/19/2023
U-1505 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
RX 04/15/2014
N205437 APREMILAST OTEZLA TABLET ORAL 30MG 8455536 03/19/2023
U-2657 TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
RX 04/15/2014
N205437 APREMILAST OTEZLA TABLET ORAL 10MG 8455536 03/19/2023
U-2658 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE
RX 04/15/2014
N205437 APREMILAST OTEZLA TABLET ORAL 10MG 6962940 03/19/2023
U-2657 TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
RX 04/15/2014
N209310 MOMETASONE FUROATE SINUVA IMPLANT IMPLANTATION 1.35MG 10232152 11/24/2034 DP
U-2272 TREATMENT OF NASAL POLYPS IN PATIENTS >=18 YEARS OF AGE WHO HAVE HAD ETHMOID SINUS SURGERY USING A CORTICOSTEROID-ELUTING (MOMETASONE FUROATE) IMPLANT
RX 12/06/2019
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 280MG 10478439 06/03/2031
U-1456 TREATMENT OF MANTLE CELL LYMPHOMA
RX 12/10/2019
N208215 EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE DESCOVY TABLET ORAL 200MG;EQ 25MG BASE 8754065 08/15/2032 DS DP
U-257 TREATMENT OF HIV INFECTION
RX 05/02/2016
N205831 METHYLPHENIDATE HYDROCHLORIDE APTENSIO XR CAPSULE, EXTENDED RELEASE ORAL 30MG 10463624 12/16/2019 DP
RX 11/26/2019
N201373 FEXOFENADINE HYDROCHLORIDE CHILDREN'S ALLEGRA HIVES SUSPENSION ORAL 30MG/5ML 8933097 08/02/2030 DP
DISCN 02/19/2015
N022563 CALCIPOTRIENE SORILUX AEROSOL, FOAM TOPICAL 0.005% 8629128 05/26/2026 DP
U-1280 USE OF A CALCIPOTRIENE CONTAINING FOAM FOR THE TREATMENT OF PSORIASIS
RX 04/17/2014
N208447 NIRAPARIB TOSYLATE ZEJULA CAPSULE ORAL EQ 100MG BASE 8143241 08/12/2027
U-2655 A METHOD OF TREATMENT OF ADVANCED OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER ASSOCIATED WITH HOMOLOGOUS RECOMBINATION DEFICIENCY (HRD) POSITIVE STATUS
RX 11/22/2019
N205437 APREMILAST OTEZLA TABLET ORAL 30MG 9018243 03/19/2023
U-2657 TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
RX 05/18/2015
N205437 APREMILAST OTEZLA TABLET ORAL 10MG 9724330 03/19/2023
U-2656 TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS
RX 07/19/2018
N205437 APREMILAST OTEZLA TABLET ORAL 10MG 8455536 03/19/2023
U-2657 TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
RX 04/15/2014
N205437 APREMILAST OTEZLA TABLET ORAL 10MG 9018243 03/19/2023
U-2656 TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS
RX 05/18/2015
N205437 APREMILAST OTEZLA TABLET ORAL 30MG 6962940 03/19/2023
U-2658 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE
RX 04/15/2014
N205437 APREMILAST OTEZLA TABLET ORAL 10MG 7659302 03/19/2023
U-2658 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE
RX 04/15/2014
N205437 APREMILAST OTEZLA TABLET ORAL 10MG 7659302 03/19/2023
U-1595 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
RX 04/15/2014
N205437 APREMILAST OTEZLA TABLET ORAL 10MG 9018243 03/19/2023
U-2658 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE
RX 05/18/2015
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 280MG 10478439 06/03/2031
U-2242 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
RX 12/10/2019
N205437 APREMILAST OTEZLA TABLET ORAL 30MG 9018243 03/19/2023
U-2658 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE
RX 05/18/2015
N205437 APREMILAST OTEZLA TABLET ORAL 30MG 6962940 03/19/2023
U-2657 TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
RX 04/15/2014
N205437 APREMILAST OTEZLA TABLET ORAL 10MG 9018243 03/19/2023
U-2657 TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
RX 05/18/2015
N209310 MOMETASONE FUROATE SINUVA IMPLANT IMPLANTATION 1.35MG 10406332 03/13/2034 DP
RX 12/06/2019
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 280MG 10478439 06/03/2031
U-1650 TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
RX 12/10/2019
N208215 EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE DESCOVY TABLET ORAL 200MG;EQ 25MG BASE 6642245 11/04/2020
U-1663 TREATMENT OF HIV-1 INFECTION
RX 05/02/2016
N208215 EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE DESCOVY TABLET ORAL 200MG;EQ 25MG BASE 6642245*PED 05/04/2021
RX
N205831 METHYLPHENIDATE HYDROCHLORIDE APTENSIO XR CAPSULE, EXTENDED RELEASE ORAL 10MG 10463624 12/16/2019 DP
RX 11/26/2019
N205437 APREMILAST OTEZLA TABLET ORAL 10MG 9018243 03/19/2023
U-1595 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
RX 05/18/2015
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 280MG 10478439 06/03/2031
U-1684 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
RX 12/10/2019
N205437 APREMILAST OTEZLA TABLET ORAL 30MG 7659302 03/19/2023
U-2658 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE
RX 04/15/2014
N205437 APREMILAST OTEZLA TABLET ORAL 30MG 10092541 05/29/2034
U-2403 TREATMENT OF PSORIASIS USING A DOSAGE TITRATION SCHEDULE
RX 10/09/2018
N205437 APREMILAST OTEZLA TABLET ORAL 30MG 9018243 03/19/2023
U-2656 TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS
RX 05/18/2015
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 280MG 10478439 06/03/2031
U-2665 TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
RX 12/10/2019
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 280MG 10478439 06/03/2031
U-1946 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
RX 12/10/2019
N209354 HALOBETASOL PROPIONATE; TAZAROTENE DUOBRII LOTION TOPICAL 0.01%;0.045% 10478502 11/02/2031 DP
U-2625 TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS
RX 11/22/2019
N020800 EPINEPHRINE ADRENACLICK INJECTABLE INTRAMUSCULAR, SUBCUTANEOUS EQ 0.15MG/DELIVERY 10166344 01/21/2025 DP
RX 11/15/2019
N202107 MIFEPRISTONE KORLYM TABLET ORAL 300MG 10495650 08/12/2036
U-1643 TREATING CUSHING'S SYNDROME
RX 12/03/2019
N212379 MINOCYCLINE HYDROCHLORIDE AMZEEQ AEROSOL, FOAM TOPICAL EQ 4% BASE 10137200 10/01/2030
U-2647 TREATMENT OF NON-NODULAR ACNE VULGARIS
RX 11/15/2019
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 9931334 12/28/2026 DP
U-2650 TREATMENT OF CF IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE USING A SOLID COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AMORPHOUS IVACAFTOR, AND LESS THAN ABOUT 30% CRYSTALLINE IVACAFTOR
RX 11/14/2019
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 280MG 10478439 06/03/2031
U-1947 TREATMENT OF MARGINAL ZONE LYMPHOMA
RX 12/10/2019
N208901 ITRACONAZOLE TOLSURA CAPSULE ORAL 65MG 10463740 06/21/2033 DP
U-2453 TREATMENT OF FUNGAL INFECTIONS, INCLUDING BLASTOMYCOSIS, HISTOPLASMOSIS, AND ASPERGILLOSIS
RX 11/27/2019
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 8598181 05/01/2027
U-2645 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
RX 11/14/2019
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 10239867 04/09/2027 DS DP
U-2653 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
RX 11/14/2019
N205552 IBRUTINIB IMBRUVICA CAPSULE ORAL 140MG 10478439 06/03/2031
U-1946 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
RX 12/10/2019
N205552 IBRUTINIB IMBRUVICA CAPSULE ORAL 140MG 10478439 06/03/2031
U-2665 TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
RX 12/10/2019
N205552 IBRUTINIB IMBRUVICA CAPSULE ORAL 140MG 10478439 06/03/2031
U-2241 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
RX 12/10/2019
N205437 APREMILAST OTEZLA TABLET ORAL 20MG 7659302 03/19/2023
U-1595 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
RX 04/15/2014
N205437 APREMILAST OTEZLA TABLET ORAL 20MG 9724330 03/19/2023
U-1595 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
RX 07/19/2018
N209210 EXENATIDE BYDUREON BCISE SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 2MG/0.85ML (2MG/0.85ML) 8329648 08/18/2026
U-2594 REDUCING FASTING PLASMA GLUCOSE IN ADULTS WITH TYPE 2 DIABETES MELLITUS BY ADMINISTERING AN EXENATIDE FORMULATION ONCE WEEKLY AS AN ADJUNCT TO DIET AND EXERCISE TO ACHIEVE A MEAN STEADY STATE PLASMA CONCENTRATION OF EXENATIDE AT LEAST 170 PG/ML
RX 11/03/2017
N208215 EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE DESCOVY TABLET ORAL 200MG;EQ 25MG BASE 7803788 02/02/2022
U-1663 TREATMENT OF HIV-1 INFECTION
RX 05/02/2016
N208215 EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE DESCOVY TABLET ORAL 200MG;EQ 25MG BASE 9296769 08/15/2032 DS DP
U-1663 TREATMENT OF HIV-1 INFECTION
RX 04/26/2016
N205437 APREMILAST OTEZLA TABLET ORAL 20MG 8455536 03/19/2023
U-1505 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
RX 04/15/2014
N212379 MINOCYCLINE HYDROCHLORIDE AMZEEQ AEROSOL, FOAM TOPICAL EQ 4% BASE 10213512 10/01/2030 DP
U-2647 TREATMENT OF NON-NODULAR ACNE VULGARIS
RX 11/15/2019
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 8415387 11/12/2027
U-2645 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
RX 11/14/2019
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 7776905 06/03/2027 DS DP
RX 11/14/2019
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 8629162 06/24/2025
U-2648 TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
RX 11/14/2019
N208447 NIRAPARIB TOSYLATE ZEJULA CAPSULE ORAL EQ 100MG BASE 8859562 08/04/2031
U-2655 A METHOD OF TREATMENT OF ADVANCED OVARIAN, FALLOPIAN TUBE, OR PRIMARY PERITONEAL CANCER ASSOCIATED WITH HOMOLOGOUS RECOMBINATION DEFICIENCY (HRD) POSITIVE STATUS
RX 11/22/2019
N205437 APREMILAST OTEZLA TABLET ORAL 30MG 10092541 05/29/2034
U-2659 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE USING A DOSAGE TITRATION SCHEDULE
RX 10/09/2018
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 140MG 10478439 06/03/2031
U-2242 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
RX 12/10/2019
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 140MG 10478439 06/03/2031
U-2241 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
RX 12/10/2019
N212379 MINOCYCLINE HYDROCHLORIDE AMZEEQ AEROSOL, FOAM TOPICAL EQ 4% BASE 8865139 10/01/2030 DP
U-2647 TREATMENT OF NON-NODULAR ACNE VULGARIS
RX 11/15/2019
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 8754224 12/28/2026 DS DP
RX 11/14/2019
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 9670163 12/28/2026 DP
U-2650 TREATMENT OF CF IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE USING A SOLID COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AMORPHOUS IVACAFTOR, AND LESS THAN ABOUT 30% CRYSTALLINE IVACAFTOR
RX 11/14/2019
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 140MG 10478439 06/03/2031
U-1684 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
RX 12/10/2019
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 9012496 07/15/2033
U-2649 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH A COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR; AND ANOTHER COMPOSITION COMPRISING IVACAFTOR
RX 11/14/2019
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 9974781 04/09/2027 DP
U-2645 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
RX 11/14/2019
N205437 APREMILAST OTEZLA TABLET ORAL 30MG 9724330 03/19/2023
U-2657 TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
RX 07/19/2018
N205437 APREMILAST OTEZLA TABLET ORAL 30MG 9724330 03/19/2023
U-2658 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE
RX 07/19/2018
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 140MG 10463668 10/24/2034
U-2654 TREATMENT OF REFRACTORY CHRONIC GRAFT-VERSUS-HOST DISEASE
RX 11/15/2019
N205831 METHYLPHENIDATE HYDROCHLORIDE APTENSIO XR CAPSULE, EXTENDED RELEASE ORAL 50MG 10463624 12/16/2019 DP
RX 11/26/2019
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 8623905 05/01/2027 DS DP
RX 11/14/2019
N205437 APREMILAST OTEZLA TABLET ORAL 30MG 6962940 03/19/2023
U-2656 TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS
RX 04/15/2014
N205437 APREMILAST OTEZLA TABLET ORAL 30MG 9724330 03/19/2023
U-2656 TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS
RX 07/19/2018
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 140MG 10478439 06/03/2031
U-1650 TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
RX 12/10/2019
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 140MG 10478439 06/03/2031
U-1947 TREATMENT OF MARGINAL ZONE LYMPHOMA
RX 12/10/2019
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 10022352 04/09/2027 DP
U-2651 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF A PHARMACEUTICAL COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
RX 11/14/2019
N205437 APREMILAST OTEZLA TABLET ORAL 30MG 8455536 03/19/2023
U-1505 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
RX 04/15/2014
N205437 APREMILAST OTEZLA TABLET ORAL 30MG 8455536 03/19/2023
U-1595 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
RX 04/15/2014
N210660 CYSTEINE HYDROCHLORIDE ELCYS SOLUTION INTRAVENOUS 500MG/10ML (50MG/ML) 10478453 01/15/2039 DP
RX 11/19/2019
N202107 MIFEPRISTONE KORLYM TABLET ORAL 300MG 10500216 03/05/2033
U-1643 TREATING CUSHING'S SYNDROME
RX 12/10/2019
N212379 MINOCYCLINE HYDROCHLORIDE AMZEEQ AEROSOL, FOAM TOPICAL EQ 4% BASE 8945516 10/01/2030 DP
RX 11/15/2019
N205437 APREMILAST OTEZLA TABLET ORAL 10MG 6962940 03/19/2023
U-2656 TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS
RX 04/15/2014
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 280MG 10478439 06/03/2031
U-2241 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
RX 12/10/2019
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 140MG 10478439 06/03/2031
U-2665 TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
RX 12/10/2019
N212379 MINOCYCLINE HYDROCHLORIDE AMZEEQ AEROSOL, FOAM TOPICAL EQ 4% BASE 10265404 10/01/2030 DP
RX 11/15/2019
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 8410274 12/28/2026 DP
RX 11/14/2019
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 7495103 05/20/2027 DS DP
RX 11/14/2019
N208564 ESTRADIOL IMVEXXY INSERT VAGINAL 0.004MG 10471072 06/18/2033
U-2316 TREATMENT OF DYSPAREUNIA
RX 12/06/2019
N208524 LORCASERIN HYDROCHLORIDE BELVIQ XR TABLET, EXTENDED RELEASE ORAL 20MG 10463676 08/31/2031
U-2661 CHRONIC WEIGHT MANAGEMENT IN ADULT PATIENTS USING AN EXTENDED RELEASE TABLET CONTAINING LORCARSERIN HYDROCHLORIDE HEMIHYDRATE
RX 12/04/2019
N205552 IBRUTINIB IMBRUVICA CAPSULE ORAL 140MG 10478439 06/03/2031
U-1947 TREATMENT OF MARGINAL ZONE LYMPHOMA
RX 12/10/2019
N205437 APREMILAST OTEZLA TABLET ORAL 20MG 10092541 05/29/2034
U-2403 TREATMENT OF PSORIASIS USING A DOSAGE TITRATION SCHEDULE
RX 10/09/2018
N208215 EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE DESCOVY TABLET ORAL 200MG;EQ 25MG BASE 8754065 08/15/2032 DS DP
U-1663 TREATMENT OF HIV-1 INFECTION
RX 05/02/2016
N209355 HALOBETASOL PROPIONATE BRYHALI LOTION TOPICAL 0.01% 10478502 11/02/2031 DP
U-2625 TOPICAL TREATMENT OF PLAQUE PSORIASIS IN ADULTS
RX 11/22/2019
N205552 IBRUTINIB IMBRUVICA CAPSULE ORAL 140MG 10478439 06/03/2031
U-1684 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
RX 12/10/2019
N205552 IBRUTINIB IMBRUVICA CAPSULE ORAL 140MG 10463668 10/24/2034
U-2654 TREATMENT OF REFRACTORY CHRONIC GRAFT-VERSUS-HOST DISEASE
RX 11/20/2019
N205437 APREMILAST OTEZLA TABLET ORAL 20MG 9724330 03/19/2023
U-2657 TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
RX 07/19/2018
N208910 VANCOMYCIN HYDROCHLORIDE FIRVANQ KIT FOR SOLUTION ORAL EQ 50MG BASE/ML 10493028 03/13/2035 DP
RX 12/05/2019
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 140MG 10478439 06/03/2031
U-1946 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
RX 12/10/2019
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 140MG 10478439 06/03/2031
U-1456 TREATMENT OF MANTLE CELL LYMPHOMA
RX 12/10/2019
N208564 ESTRADIOL IMVEXXY INSERT VAGINAL 0.004MG 10471072 06/18/2033
U-2317 TREATMENT OF A SYMPTOM OF VULVAR AND VAGINAL ATROPHY
RX 12/06/2019
N205552 IBRUTINIB IMBRUVICA CAPSULE ORAL 140MG 10478439 06/03/2031
U-1650 TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
RX 12/10/2019
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 8354427 07/06/2026
U-2646 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE ONE F508DEL MUTATION AND ONE R117H MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
RX 11/14/2019
N205437 APREMILAST OTEZLA TABLET ORAL 20MG 9018243 03/19/2023
U-1595 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
RX 05/18/2015
N205437 APREMILAST OTEZLA TABLET ORAL 20MG 8455536 03/19/2023
U-2658 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE
RX 04/15/2014
N205437 APREMILAST OTEZLA TABLET ORAL 20MG 9018243 03/19/2023
U-2657 TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
RX 05/18/2015
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 8324242 08/05/2027
U-2645 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
RX 11/14/2019
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 10081621 03/25/2031 DP
U-2652 TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621
RX 11/14/2019
N205552 IBRUTINIB IMBRUVICA CAPSULE ORAL 140MG 10478439 06/03/2031
U-1456 TREATMENT OF MANTLE CELL LYMPHOMA
RX 12/10/2019
N205552 IBRUTINIB IMBRUVICA CAPSULE ORAL 140MG 10478439 06/03/2031
U-2242 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
RX 12/10/2019
N205437 APREMILAST OTEZLA TABLET ORAL 20MG 8455536 03/19/2023
U-2657 TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
RX 04/15/2014
N205437 APREMILAST OTEZLA TABLET ORAL 20MG 10092541 05/29/2034
U-2659 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE USING A DOSAGE TITRATION SCHEDULE
RX 10/09/2018
N205437 APREMILAST OTEZLA TABLET ORAL 20MG 9018243 03/19/2023
U-2658 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE
RX 05/18/2015
N205437 APREMILAST OTEZLA TABLET ORAL 20MG 9724330 03/19/2023
U-2658 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE
RX 07/19/2018
N205437 APREMILAST OTEZLA TABLET ORAL 20MG 9724330 03/19/2023
U-2656 TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS
RX 07/19/2018
N205437 APREMILAST OTEZLA TABLET ORAL 20MG 7659302 03/19/2023
U-2658 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE
RX 04/15/2014
N205437 APREMILAST OTEZLA TABLET ORAL 20MG 6962940 03/19/2023
U-1504 USE OF OTEZLA (APREMILAST) FOR INHIBITING PDE4
RX 04/15/2014
N210797 AFAMELANOTIDE SCENESSE IMPLANT SUBCUTANEOUS 16MG 8334265 03/11/2029
U-2638 INCREASE PAIN-FREE LIGHT EXPOSURE IN ADULT PATIENTS WITH A HISTORY OF PHOTOTOXIC REACTIONS FROM ERYTHROPOIETIC PROTOPORPHYRIA (EPP)
RX 11/06/2019
N212273 ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR TRIKAFTA (COPACKAGED) TABLET, TABLET ORAL 100MG,75MG,50MG;N/A,150MG,N/A 7645789 05/01/2027 DS DP
RX 11/14/2019
N205437 APREMILAST OTEZLA TABLET ORAL 20MG 6962940 03/19/2023
U-2658 TREATMENT OF ADULT PATIENTS WITH ORAL ULCERS ASSOCIATED WITH BEHCET'S DISEASE
RX 04/15/2014
N205437 APREMILAST OTEZLA TABLET ORAL 20MG 7659302 03/19/2023
U-2657 TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
RX 04/15/2014
N205437 APREMILAST OTEZLA TABLET ORAL 20MG 8455536 03/19/2023
U-1595 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
RX 04/15/2014
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 420MG 10463668 10/24/2034
U-2654 TREATMENT OF REFRACTORY CHRONIC GRAFT-VERSUS-HOST DISEASE
RX 11/15/2019
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 420MG 10478439 06/03/2031
U-1456 TREATMENT OF MANTLE CELL LYMPHOMA
RX 12/10/2019
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 420MG 10478439 06/03/2031
U-1946 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
RX 12/10/2019
N205437 APREMILAST OTEZLA TABLET ORAL 20MG 6962940 03/19/2023
U-2656 TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS
RX 04/15/2014
N205437 APREMILAST OTEZLA TABLET ORAL 20MG 6962940 03/19/2023
U-2657 TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
RX 04/15/2014
N205437 APREMILAST OTEZLA TABLET ORAL 20MG 9724330 03/19/2023
U-1561 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
RX 07/19/2018
N205437 APREMILAST OTEZLA TABLET ORAL 20MG 9018243 03/19/2023
U-1505 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
RX 05/18/2015
N205437 APREMILAST OTEZLA TABLET ORAL 20MG 7659302 03/19/2023
U-1505 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
RX 04/15/2014
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 420MG 10478439 06/03/2031
U-1650 TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA
RX 12/10/2019
N205437 APREMILAST OTEZLA TABLET ORAL 20MG 9018243 03/19/2023
U-2656 TREATMENT OF ADULT PATIENTS WITH ACTIVE PSORIATIC ARTHRITIS
RX 05/18/2015
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 420MG 10478439 06/03/2031
U-2241 TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
RX 12/10/2019
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 420MG 10478439 06/03/2031
U-1684 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
RX 12/10/2019
N212477 LEDIPASVIR; SOFOSBUVIR HARVONI PELLETS ORAL 45MG;200MG/PACKET 10456414 09/14/2032 DP
RX 11/20/2019
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 420MG 10478439 06/03/2031
U-1947 TREATMENT OF MARGINAL ZONE LYMPHOMA
RX 12/10/2019
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 420MG 10478439 06/03/2031
U-2665 TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
RX 12/10/2019
N210563 IBRUTINIB IMBRUVICA TABLET ORAL 420MG 10478439 06/03/2031
U-2242 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
RX 12/10/2019
N210797 AFAMELANOTIDE SCENESSE IMPLANT SUBCUTANEOUS 16MG 10076555 02/11/2025
U-2638 INCREASE PAIN-FREE LIGHT EXPOSURE IN ADULT PATIENTS WITH A HISTORY OF PHOTOTOXIC REACTIONS FROM ERYTHROPOIETIC PROTOPORPHYRIA (EPP)
RX 11/06/2019

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