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 |
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 2MG | 10220023 | 12/10/2035 |
U-3103
TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE
|
RX | 04/14/2021 | |||
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 20MG | 10220023 | 12/10/2035 |
U-3103
TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE
|
RX | 04/14/2021 | |||
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 6MG | 10220023 | 12/10/2035 |
U-3103
TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE
|
RX | 04/14/2021 | |||
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 9MG | 10220023 | 12/10/2035 |
U-3103
TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE
|
RX | 04/14/2021 | |||
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 4MG | 10220023 | 12/10/2035 |
U-3103
TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE
|
RX | 04/14/2021 | |||
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 5MG | 10220023 | 12/10/2035 |
U-3103
TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE
|
RX | 04/14/2021 | |||
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 3MG | 10220023 | 12/10/2035 |
U-3103
TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE
|
RX | 04/14/2021 | |||
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 8MG | 10220023 | 12/10/2035 |
U-3103
TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE
|
RX | 04/14/2021 | |||
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 7MG | 10220023 | 12/10/2035 |
U-3103
TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE
|
RX | 04/14/2021 | |||
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 10MG | 10220023 | 12/10/2035 |
U-3103
TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS USING A DOSE TITRATION SCHEDULE FOLLOWED BY A MAINTENANCE DOSE
|
RX | 04/14/2021 | |||
| N204410 | MACITENTAN | OPSUMIT | TABLET | ORAL | 10MG | 10946015 | 11/25/2026 | DP |
U-1445
METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING MACITENTAN AND A POLYSORBATE, WHERIN THE POLYSORBATE REPRESENTS 0.1 TO 1% OF THE WEIGHT OF SAID PHARMACEUTICAL COMPOSITION
|
RX | 04/08/2021 | ||
| N209296 | APREPITANT | CINVANTI | EMULSION | INTRAVENOUS | 130MG/18ML (7.2MG/ML) | 10953018 | 09/18/2035 |
U-2161
TREATMENT OF NAUSEA AND VOMITING, INCLUDING THE PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF HIGHLY OR MODERATELY EMETOGENIC CANCER CHEMOTHERAPY
|
RX | 04/08/2021 | |||
| N208910 | VANCOMYCIN HYDROCHLORIDE | FIRVANQ KIT | FOR SOLUTION | ORAL | EQ 25MG BASE/ML | 10959946 | 03/13/2035 | DP |
|
RX | 04/15/2021 | ||
| N208910 | VANCOMYCIN HYDROCHLORIDE | FIRVANQ KIT | FOR SOLUTION | ORAL | EQ 50MG BASE/ML | 10959946 | 03/13/2035 | DP |
|
RX | 04/15/2021 | ||
| N208910 | VANCOMYCIN HYDROCHLORIDE | FIRVANQ KIT | FOR SOLUTION | ORAL | EQ 25MG BASE/ML | 10959947 | 03/13/2035 | DP |
U-3104
TREATMENT OF C. DIFFICILE-ASSOCIATED DIARRHEA
|
RX | 04/15/2021 | ||
| N208910 | VANCOMYCIN HYDROCHLORIDE | FIRVANQ KIT | FOR SOLUTION | ORAL | EQ 25MG BASE/ML | 10959947 | 03/13/2035 | DP |
U-3105
TREATMENT OF STAPHYLOCOCCAL ENTEROCOLITIS
|
RX | 04/15/2021 | ||
| N208910 | VANCOMYCIN HYDROCHLORIDE | FIRVANQ KIT | FOR SOLUTION | ORAL | EQ 50MG BASE/ML | 10959947 | 03/13/2035 | DP |
U-3104
TREATMENT OF C. DIFFICILE-ASSOCIATED DIARRHEA
|
RX | 04/15/2021 | ||
| N208910 | VANCOMYCIN HYDROCHLORIDE | FIRVANQ KIT | FOR SOLUTION | ORAL | EQ 50MG BASE/ML | 10959947 | 03/13/2035 | DP |
U-3105
TREATMENT OF STAPHYLOCOCCAL ENTEROCOLITIS
|
RX | 04/15/2021 | ||
| N208910 | VANCOMYCIN HYDROCHLORIDE | FIRVANQ KIT | FOR SOLUTION | ORAL | EQ 25MG BASE/ML | 10959948 | 03/13/2035 | DP |
U-3104
TREATMENT OF C. DIFFICILE-ASSOCIATED DIARRHEA
|
RX | 04/15/2021 | ||
| N208910 | VANCOMYCIN HYDROCHLORIDE | FIRVANQ KIT | FOR SOLUTION | ORAL | EQ 25MG BASE/ML | 10959948 | 03/13/2035 | DP |
U-3105
TREATMENT OF STAPHYLOCOCCAL ENTEROCOLITIS
|
RX | 04/15/2021 | ||
| N208910 | VANCOMYCIN HYDROCHLORIDE | FIRVANQ KIT | FOR SOLUTION | ORAL | EQ 50MG BASE/ML | 10959948 | 03/13/2035 | DP |
U-3104
TREATMENT OF C. DIFFICILE-ASSOCIATED DIARRHEA
|
RX | 04/15/2021 | ||
| N208910 | VANCOMYCIN HYDROCHLORIDE | FIRVANQ KIT | FOR SOLUTION | ORAL | EQ 50MG BASE/ML | 10959948 | 03/13/2035 | DP |
U-3105
TREATMENT OF STAPHYLOCOCCAL ENTEROCOLITIS
|
RX | 04/15/2021 | ||
| N208910 | VANCOMYCIN HYDROCHLORIDE | FIRVANQ KIT | FOR SOLUTION | ORAL | EQ 25MG BASE/ML | 10959949 | 03/13/2035 | DP |
U-3104
TREATMENT OF C. DIFFICILE-ASSOCIATED DIARRHEA
|
RX | 04/15/2021 | ||
| N208910 | VANCOMYCIN HYDROCHLORIDE | FIRVANQ KIT | FOR SOLUTION | ORAL | EQ 25MG BASE/ML | 10959949 | 03/13/2035 | DP |
U-3105
TREATMENT OF STAPHYLOCOCCAL ENTEROCOLITIS
|
RX | 04/15/2021 | ||
| N208910 | VANCOMYCIN HYDROCHLORIDE | FIRVANQ KIT | FOR SOLUTION | ORAL | EQ 50MG BASE/ML | 10959949 | 03/13/2035 | DP |
U-3104
TREATMENT OF C. DIFFICILE-ASSOCIATED DIARRHEA
|
RX | 04/15/2021 | ||
| N208910 | VANCOMYCIN HYDROCHLORIDE | FIRVANQ KIT | FOR SOLUTION | ORAL | EQ 50MG BASE/ML | 10959949 | 03/13/2035 | DP |
U-3105
TREATMENT OF STAPHYLOCOCCAL ENTEROCOLITIS
|
RX | 04/15/2021 | ||
| N211340 | AMLODIPINE BENZOATE | KATERZIA | SUSPENSION | ORAL | EQ 1MG BASE/ML | 10959991 | 10/06/2037 |
U-158
ANGINA
|
RX | 04/15/2021 | |||
| N211340 | AMLODIPINE BENZOATE | KATERZIA | SUSPENSION | ORAL | EQ 1MG BASE/ML | 10959991 | 10/06/2037 |
U-39
ANGINA PECTORIS
|
RX | 04/15/2021 | |||
| N207981 | TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE | LONSURF | TABLET | ORAL | EQ 8.19MG BASE;20MG | 10960004 | 02/03/2037 |
U-2642
METHOD OF TREATING CANCER BY DETECTING A CREATININE CLEARANCE OF A PATIENT AND ADMINISTERING LONSURF
|
RX | 04/09/2021 | |||
| N207981 | TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE | LONSURF | TABLET | ORAL | EQ 6.14MG BASE;15MG | 10960004 | 02/03/2037 |
U-2642
METHOD OF TREATING CANCER BY DETECTING A CREATININE CLEARANCE OF A PATIENT AND ADMINISTERING LONSURF
|
RX | 04/09/2021 | |||
| N205718 | NETUPITANT; PALONOSETRON HYDROCHLORIDE | AKYNZEO | CAPSULE | ORAL | 300MG;EQ 0.5MG BASE | 10961195 | 09/25/2035 | DS | DP |
|
RX | 04/15/2021 | |
| N022201 | DEGARELIX ACETATE | FIRMAGON | POWDER | SUBCUTANEOUS | EQ 80MG BASE/VIAL | 10973870 | 02/10/2029 |
U-1978
TREATMENT OF ADVANCED PROSTATE CANCER WITH A REDUCED LIKELIHOOD OF CAUSING A GONADOTROPHIN RELEASING HORMONE AGONIST SIDE-EFFECT
|
RX | 04/13/2021 | |||
| N022201 | DEGARELIX ACETATE | FIRMAGON | POWDER | SUBCUTANEOUS | EQ 120MG BASE/VIAL | 10973870 | 02/10/2029 |
U-1978
TREATMENT OF ADVANCED PROSTATE CANCER WITH A REDUCED LIKELIHOOD OF CAUSING A GONADOTROPHIN RELEASING HORMONE AGONIST SIDE-EFFECT
|
RX | 04/13/2021 | |||
| N214517 | TASIMELTEON | HETLIOZ LQ | SUSPENSION | ORAL | 4MG/ML | 10980770 | 01/25/2033 |
U-3106
TREATMENT OF NIGHTTIME SLEEP DISTURBANCES IN SMITH-MAGENISSYNDROME BY AVOIDING THE ADMINISTRATION OF TASIMELTEON TO SMOKERS OR TO PATIENTS BEING TREATED WITH A CYP1A2 INHIBITOR
|
RX | 04/15/2021 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 6515117 | 10/04/2025 | DS | 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
|
DISCN | 11/17/2017 | |
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 6515117 | 10/04/2025 | DS | 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
|
DISCN | 11/15/2017 | |
| N209210 | EXENATIDE | BYDUREON BCISE | SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/0.85ML (2MG/0.85ML) | 6515117 | 10/04/2025 | DS | 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 | 08/21/2019 | |
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 6515117*PED | 04/04/2026 |
|
DISCN | ||||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 6515117*PED | 04/04/2026 |
|
DISCN | ||||
| N209210 | EXENATIDE | BYDUREON BCISE | SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/0.85ML (2MG/0.85ML) | 6515117*PED | 04/04/2026 |
|
RX | ||||
| N202992 | TERIFLUNOMIDE | AUBAGIO | TABLET | ORAL | 7MG | 6794410 | 09/12/2026 |
U-1285
TREATMENT OF PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS
|
RX | 08/20/2013 | |||
| N202992 | TERIFLUNOMIDE | AUBAGIO | TABLET | ORAL | 14MG | 6794410 | 09/12/2026 |
U-1285
TREATMENT OF PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS
|
RX | 08/20/2013 | |||
| N202992 | TERIFLUNOMIDE | AUBAGIO | TABLET | ORAL | 7MG | 6794410*PED | 03/12/2027 |
|
RX | ||||
| N202992 | TERIFLUNOMIDE | AUBAGIO | TABLET | ORAL | 14MG | 6794410*PED | 03/12/2027 |
|
RX | ||||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 6824822 | 10/09/2022 | DP |
|
DISCN | 03/28/2014 | ||
| N209210 | EXENATIDE | BYDUREON BCISE | SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/0.85ML (2MG/0.85ML) | 6824822 | 10/09/2022 | DP |
|
RX | 11/03/2017 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 6824822*PED | 04/09/2023 |
|
DISCN | ||||
| N209210 | EXENATIDE | BYDUREON BCISE | SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/0.85ML (2MG/0.85ML) | 6824822*PED | 04/09/2023 |
|
RX | ||||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 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
|
DISCN | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 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
|
DISCN | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 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
|
DISCN | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 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
|
DISCN | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 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
|
DISCN | 03/28/2014 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 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
|
DISCN | 03/28/2014 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 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
|
DISCN | 03/28/2014 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 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
|
DISCN | 03/28/2014 | ||
| 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) | 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) | 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) | 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 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 7456254*PED | 12/30/2025 |
|
DISCN | ||||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 7456254*PED | 12/30/2025 |
|
DISCN | ||||
| N209210 | EXENATIDE | BYDUREON BCISE | SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/0.85ML (2MG/0.85ML) | 7456254*PED | 12/30/2025 |
|
RX | ||||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 7563871 | 04/15/2024 | DP |
|
DISCN | 03/28/2014 | ||
| N209210 | EXENATIDE | BYDUREON BCISE | SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/0.85ML (2MG/0.85ML) | 7563871 | 04/15/2024 | DP |
|
RX | 11/03/2017 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 7563871*PED | 10/15/2024 |
|
DISCN | ||||
| N209210 | EXENATIDE | BYDUREON BCISE | SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/0.85ML (2MG/0.85ML) | 7563871*PED | 10/15/2024 |
|
RX | ||||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 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
|
DISCN | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 7612176 | 04/13/2025 | 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
|
DISCN | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 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
|
DISCN | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 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
|
DISCN | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 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
|
DISCN | 03/28/2014 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 7612176 | 04/13/2025 | 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
|
DISCN | 03/28/2014 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 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
|
DISCN | 03/28/2014 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 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
|
DISCN | 03/28/2014 | ||
| 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) | 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 | ||
| 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 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 7612176*PED | 10/13/2025 |
|
DISCN | ||||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 7612176*PED | 10/13/2025 |
|
DISCN | ||||
| N209210 | EXENATIDE | BYDUREON BCISE | SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/0.85ML (2MG/0.85ML) | 7612176*PED | 10/13/2025 |
|
RX | ||||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 8216180 | 01/12/2028 | DP |
|
DISCN | 03/28/2014 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 8216180*PED | 07/12/2028 |
|
DISCN | ||||
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 2MG | 8273779 | 12/17/2025 |
U-2774
TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
|
RX | 04/14/2021 | |||
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 20MG | 8273779 | 12/17/2025 |
U-2774
TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
|
RX | 04/14/2021 | |||
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 6MG | 8273779 | 12/17/2025 |
U-2774
TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
|
RX | 04/14/2021 | |||
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 9MG | 8273779 | 12/17/2025 |
U-2774
TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
|
RX | 04/14/2021 | |||
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 4MG | 8273779 | 12/17/2025 |
U-2774
TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
|
RX | 04/14/2021 | |||
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 5MG | 8273779 | 12/17/2025 |
U-2774
TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
|
RX | 04/14/2021 | |||
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 3MG | 8273779 | 12/17/2025 |
U-2774
TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
|
RX | 04/14/2021 | |||
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 8MG | 8273779 | 12/17/2025 |
U-2774
TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
|
RX | 04/14/2021 | |||
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 7MG | 8273779 | 12/17/2025 |
U-2774
TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
|
RX | 04/14/2021 | |||
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 10MG | 8273779 | 12/17/2025 |
U-2774
TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
|
RX | 04/14/2021 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 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
|
DISCN | 01/10/2013 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 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
|
DISCN | 01/10/2013 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 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
|
DISCN | 01/10/2013 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 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
|
DISCN | 01/10/2013 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 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
|
DISCN | 01/10/2013 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 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
|
DISCN | 01/10/2013 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 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
|
DISCN | 01/10/2013 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 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
|
DISCN | 03/28/2014 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 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
|
DISCN | 03/28/2014 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 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
|
DISCN | 03/28/2014 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 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
|
DISCN | 03/28/2014 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 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
|
DISCN | 03/28/2014 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 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
|
DISCN | 03/28/2014 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 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
|
DISCN | 03/28/2014 | |||
| 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 | |||
| 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) | 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 | |||
| 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 | |||
| 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) | 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 | |||
| 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 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 8329648*PED | 02/18/2027 |
|
DISCN | ||||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 8329648*PED | 02/18/2027 |
|
DISCN | ||||
| N209210 | EXENATIDE | BYDUREON BCISE | SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/0.85ML (2MG/0.85ML) | 8329648*PED | 02/18/2027 |
|
RX | ||||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 8361972 | 03/21/2028 |
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
|
DISCN | 11/17/2017 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 8361972 | 03/21/2028 |
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
|
DISCN | 11/15/2017 | |||
| N209210 | EXENATIDE | BYDUREON BCISE | SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/0.85ML (2MG/0.85ML) | 8361972 | 03/21/2028 |
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 | 08/21/2019 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 8361972*PED | 09/21/2028 |
|
DISCN | ||||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 8361972*PED | 09/21/2028 |
|
DISCN | ||||
| N209210 | EXENATIDE | BYDUREON BCISE | SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/0.85ML (2MG/0.85ML) | 8361972*PED | 09/21/2028 |
|
RX | ||||
| N214155 | ORITAVANCIN DIPHOSPHATE | KIMYRSA | POWDER | INTRAVENOUS | EQ 1.2GM BASE/VIAL | 8420592 | 08/29/2029 |
U-3101
TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS WITH A SINGLE DOSE OF 1200MG ORITAVANCIN OR ITS SINGLE DOSE EQUIVALENT
|
RX | 04/12/2021 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 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
|
DISCN | 05/29/2013 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 8431685 | 04/13/2025 | 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
|
DISCN | 05/29/2013 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 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
|
DISCN | 05/29/2013 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 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
|
DISCN | 05/29/2013 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 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
|
DISCN | 03/28/2014 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 8431685 | 04/13/2025 | 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
|
DISCN | 03/28/2014 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 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
|
DISCN | 03/28/2014 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 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
|
DISCN | 03/28/2014 | ||
| 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) | 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 | ||
| 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) | 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 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 8431685*PED | 10/13/2025 |
|
DISCN | ||||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 8431685*PED | 10/13/2025 |
|
DISCN | ||||
| N209210 | EXENATIDE | BYDUREON BCISE | SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/0.85ML (2MG/0.85ML) | 8431685*PED | 10/13/2025 |
|
RX | ||||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 8439864 | 03/25/2028 | DP |
|
DISCN | 03/28/2014 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 8439864*PED | 09/25/2028 |
|
DISCN | ||||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 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
|
DISCN | 07/10/2013 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 8461105 | 04/13/2025 | 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
|
DISCN | 07/10/2013 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 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
|
DISCN | 07/10/2013 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 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
|
DISCN | 07/10/2013 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 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
|
DISCN | 03/28/2014 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 8461105 | 04/13/2025 | 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
|
DISCN | 03/28/2014 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 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
|
DISCN | 03/28/2014 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 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
|
DISCN | 03/28/2014 | ||
| 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 | ||
| 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 | ||
| 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) | 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 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 8461105*PED | 10/13/2025 |
|
DISCN | ||||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 8461105*PED | 10/13/2025 |
|
DISCN | ||||
| N209210 | EXENATIDE | BYDUREON BCISE | SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/0.85ML (2MG/0.85ML) | 8461105*PED | 10/13/2025 |
|
RX | ||||
| N209210 | EXENATIDE | BYDUREON BCISE | SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/0.85ML (2MG/0.85ML) | 8501698 | 06/20/2027 |
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 | 08/21/2019 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 8501698 | 06/20/2027 | 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
|
DISCN | 11/17/2017 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 8501698 | 06/20/2027 | 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
|
DISCN | 11/15/2017 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 8501698*PED | 12/20/2027 |
|
DISCN | ||||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 8501698*PED | 12/20/2027 |
|
DISCN | ||||
| N209210 | EXENATIDE | BYDUREON BCISE | SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/0.85ML (2MG/0.85ML) | 8501698*PED | 12/20/2027 |
|
RX | ||||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 8690837 | 05/19/2029 | DP |
|
DISCN | 11/15/2017 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 8690837*PED | 11/19/2029 |
|
DISCN | ||||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 8721615 | 01/18/2030 | DP |
|
DISCN | 11/15/2017 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 8721615*PED | 07/18/2030 |
|
DISCN | ||||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 8758292 | 11/12/2027 | DP |
|
DISCN | 11/15/2017 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 8758292*PED | 05/12/2028 |
|
DISCN | ||||
| N202992 | TERIFLUNOMIDE | AUBAGIO | TABLET | ORAL | 7MG | 8802735 | 09/14/2030 | DP |
|
RX | 09/11/2014 | ||
| N202992 | TERIFLUNOMIDE | AUBAGIO | TABLET | ORAL | 14MG | 8802735 | 09/14/2030 | DP |
|
RX | 09/11/2014 | ||
| N202992 | TERIFLUNOMIDE | AUBAGIO | TABLET | ORAL | 7MG | 8802735*PED | 03/14/2031 |
|
RX | ||||
| N202992 | TERIFLUNOMIDE | AUBAGIO | TABLET | ORAL | 14MG | 8802735*PED | 03/14/2031 |
|
RX | ||||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 8827963 | 02/04/2029 | DP |
|
DISCN | 11/15/2017 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 8827963*PED | 08/04/2029 |
|
DISCN | ||||
| 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 | ||
| 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 | ||
| 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) | 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) | 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) | 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) | 8895033*PED | 04/04/2031 |
|
RX | ||||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 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
|
DISCN | 01/06/2015 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 8906851 | 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
|
DISCN | 01/06/2015 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 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
|
DISCN | 01/06/2015 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 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
|
DISCN | 01/06/2015 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 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
|
DISCN | 01/06/2015 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 8906851 | 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
|
DISCN | 01/06/2015 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 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
|
DISCN | 01/06/2015 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 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
|
DISCN | 01/06/2015 | |||
| 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) | 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) | 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 | |||
| 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 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 8906851*PED | 02/18/2027 |
|
DISCN | ||||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 8906851*PED | 02/18/2027 |
|
DISCN | ||||
| N209210 | EXENATIDE | BYDUREON BCISE | SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/0.85ML (2MG/0.85ML) | 8906851*PED | 02/18/2027 |
|
RX | ||||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 8998876 | 01/07/2030 | DP |
|
DISCN | 11/15/2017 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 8998876*PED | 07/07/2030 |
|
DISCN | ||||
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 2MG | 9000018 | 11/16/2024 |
U-3102
REDUCTION OF CIRCULATING LYMPHOCYTES IN TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
|
RX | 04/14/2021 | |||
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 20MG | 9000018 | 11/16/2024 |
U-3102
REDUCTION OF CIRCULATING LYMPHOCYTES IN TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
|
RX | 04/14/2021 | |||
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 6MG | 9000018 | 11/16/2024 |
U-3102
REDUCTION OF CIRCULATING LYMPHOCYTES IN TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
|
RX | 04/14/2021 | |||
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 9MG | 9000018 | 11/16/2024 |
U-3102
REDUCTION OF CIRCULATING LYMPHOCYTES IN TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
|
RX | 04/14/2021 | |||
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 4MG | 9000018 | 11/16/2024 |
U-3102
REDUCTION OF CIRCULATING LYMPHOCYTES IN TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
|
RX | 04/14/2021 | |||
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 5MG | 9000018 | 11/16/2024 |
U-3102
REDUCTION OF CIRCULATING LYMPHOCYTES IN TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
|
RX | 04/14/2021 | |||
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 3MG | 9000018 | 11/16/2024 |
U-3102
REDUCTION OF CIRCULATING LYMPHOCYTES IN TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
|
RX | 04/14/2021 | |||
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 8MG | 9000018 | 11/16/2024 |
U-3102
REDUCTION OF CIRCULATING LYMPHOCYTES IN TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
|
RX | 04/14/2021 | |||
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 7MG | 9000018 | 11/16/2024 |
U-3102
REDUCTION OF CIRCULATING LYMPHOCYTES IN TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
|
RX | 04/14/2021 | |||
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 10MG | 9000018 | 11/16/2024 |
U-3102
REDUCTION OF CIRCULATING LYMPHOCYTES IN TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
|
RX | 04/14/2021 | |||
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 2MG | 9062014 | 05/06/2032 | DS | DP |
U-2774
TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
|
RX | 04/14/2021 | |
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 20MG | 9062014 | 05/06/2032 | DS | DP |
U-2774
TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
|
RX | 04/14/2021 | |
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 6MG | 9062014 | 05/06/2032 | DS | DP |
U-2774
TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
|
RX | 04/14/2021 | |
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 9MG | 9062014 | 05/06/2032 | DS | DP |
U-2774
TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
|
RX | 04/14/2021 | |
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 4MG | 9062014 | 05/06/2032 | DS | DP |
U-2774
TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
|
RX | 04/14/2021 | |
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 5MG | 9062014 | 05/06/2032 | DS | DP |
U-2774
TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
|
RX | 04/14/2021 | |
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 3MG | 9062014 | 05/06/2032 | DS | DP |
U-2774
TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
|
RX | 04/14/2021 | |
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 8MG | 9062014 | 05/06/2032 | DS | DP |
U-2774
TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
|
RX | 04/14/2021 | |
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 7MG | 9062014 | 05/06/2032 | DS | DP |
U-2774
TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
|
RX | 04/14/2021 | |
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 10MG | 9062014 | 05/06/2032 | DS | DP |
U-2774
TREATMENT OF RELAPSING FORMS OF MULTIPLE SCLEROSIS (MS), TO INCLUDE CLINICALLY ISOLATED SYNDROME, RELAPSING-REMITTING DISEASE, AND ACTIVE SECONDARY PROGRESSIVE DISEASE, IN ADULTS
|
RX | 04/14/2021 | |
| N202992 | TERIFLUNOMIDE | AUBAGIO | TABLET | ORAL | 7MG | 9186346 | 02/04/2034 |
U-1786
TREATMENT OF PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS WHILE MANAGING THE RISK OF TERIFLUNOMIDE AND ROSUVASTATIN INTERACTION BY LIMITING THE ROSUVASTATIN DOSE TO NO MORE THAN 10MG AND/OR ADMINISTERING ABOUT HALF THE NORMAL DOSE
|
RX | 12/15/2015 | |||
| N202992 | TERIFLUNOMIDE | AUBAGIO | TABLET | ORAL | 14MG | 9186346 | 02/04/2034 |
U-1786
TREATMENT OF PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS WHILE MANAGING THE RISK OF TERIFLUNOMIDE AND ROSUVASTATIN INTERACTION BY LIMITING THE ROSUVASTATIN DOSE TO NO MORE THAN 10MG AND/OR ADMINISTERING ABOUT HALF THE NORMAL DOSE
|
RX | 12/15/2015 | |||
| N202992 | TERIFLUNOMIDE | AUBAGIO | TABLET | ORAL | 7MG | 9186346*PED | 08/04/2034 |
|
RX | ||||
| N202992 | TERIFLUNOMIDE | AUBAGIO | TABLET | ORAL | 14MG | 9186346*PED | 08/04/2034 |
|
RX | ||||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 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
|
DISCN | 02/17/2016 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 9238076 | 04/15/2024 | 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
|
DISCN | 02/17/2016 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 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
|
DISCN | 02/17/2016 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 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
|
DISCN | 02/17/2016 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 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
|
DISCN | 02/17/2016 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 9238076 | 04/15/2024 | 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
|
DISCN | 02/17/2016 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 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
|
DISCN | 02/17/2016 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 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
|
DISCN | 02/17/2016 | ||
| 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) | 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) | 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) | 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 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 9238076*PED | 10/15/2024 |
|
DISCN | ||||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 9238076*PED | 10/15/2024 |
|
DISCN | ||||
| N209210 | EXENATIDE | BYDUREON BCISE | SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/0.85ML (2MG/0.85ML) | 9238076*PED | 10/15/2024 |
|
RX | ||||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 9320853 | 03/25/2028 | DP |
|
DISCN | 11/15/2017 | ||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 9320853*PED | 09/25/2028 |
|
DISCN | ||||
| N214155 | ORITAVANCIN DIPHOSPHATE | KIMYRSA | POWDER | INTRAVENOUS | EQ 1.2GM BASE/VIAL | 9649352 | 07/16/2035 | DS | DP |
|
RX | 04/12/2021 | |
| N214155 | ORITAVANCIN DIPHOSPHATE | KIMYRSA | POWDER | INTRAVENOUS | EQ 1.2GM BASE/VIAL | 9682061 | 04/26/2030 |
U-3101
TREATMENT OF ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS WITH A SINGLE DOSE OF 1200MG ORITAVANCIN OR ITS SINGLE DOSE EQUIVALENT
|
RX | 04/12/2021 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 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
|
DISCN | 03/06/2018 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 9884092 | 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
|
DISCN | 03/06/2018 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 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
|
DISCN | 03/06/2018 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 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
|
DISCN | 03/06/2018 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 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
|
DISCN | 03/06/2018 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 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
|
DISCN | 03/06/2018 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 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
|
DISCN | 03/06/2018 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 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
|
DISCN | 03/06/2018 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 9884092 | 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
|
DISCN | 03/06/2018 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 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
|
DISCN | 03/06/2018 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 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
|
DISCN | 03/06/2018 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 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
|
DISCN | 03/06/2018 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 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
|
DISCN | 03/06/2018 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 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
|
DISCN | 03/06/2018 | |||
| 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) | 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 | |||
| 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 | |||
| 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 | |||
| 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) | 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 | |||
| 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 | |||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/VIAL | 9884092*PED | 02/18/2027 |
|
DISCN | ||||
| N022200 | EXENATIDE SYNTHETIC | BYDUREON PEN | FOR SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG | 9884092*PED | 02/18/2027 |
|
DISCN | ||||
| N209210 | EXENATIDE | BYDUREON BCISE | SUSPENSION, EXTENDED RELEASE | SUBCUTANEOUS | 2MG/0.85ML (2MG/0.85ML) | 9884092*PED | 02/18/2027 |
|
RX | ||||
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 2MG | RE43728 | 11/16/2024 | DS | DP |
|
RX | 04/14/2021 | |
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 20MG | RE43728 | 11/16/2024 | DS | DP |
|
RX | 04/14/2021 | |
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 6MG | RE43728 | 11/16/2024 | DS | DP |
|
RX | 04/14/2021 | |
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 9MG | RE43728 | 11/16/2024 | DS | DP |
|
RX | 04/14/2021 | |
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 4MG | RE43728 | 11/16/2024 | DS | DP |
|
RX | 04/14/2021 | |
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 5MG | RE43728 | 11/16/2024 | DS | DP |
|
RX | 04/14/2021 | |
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 3MG | RE43728 | 11/16/2024 | DS | DP |
|
RX | 04/14/2021 | |
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 8MG | RE43728 | 11/16/2024 | DS | DP |
|
RX | 04/14/2021 | |
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 7MG | RE43728 | 11/16/2024 | DS | DP |
|
RX | 04/14/2021 | |
| N213498 | PONESIMOD | PONVORY | TABLET | ORAL | 10MG | RE43728 | 11/16/2024 | DS | DP |
|
RX | 04/14/2021 | |
| N206488 | ETEPLIRSEN | EXONDYS 51 | SOLUTION | INTRAVENOUS | 100MG/2ML (50MG/ML) | RE48468 | 10/27/2028 |
U-2097
TREATMENT OF DMD IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING
|
RX | 04/12/2021 | |||
| N206488 | ETEPLIRSEN | EXONDYS 51 | SOLUTION | INTRAVENOUS | 500MG/10ML (50MG/ML) | RE48468 | 10/27/2028 |
U-2097
TREATMENT OF DMD IN PATIENTS HAVING A MUTATION OF THE DMD GENE THAT IS AMENABLE TO EXON 51 SKIPPING
|
RX | 04/12/2021 |
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Last Updated April 16, 2021.
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