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.
| 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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