Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Newly Added Patents

About This List
  • This screen lists the current month's NEW ADDITIONS or NEW CHANGES to the patents for drugs listed in the Orange Book.
  • This list will be purged after the Cumulative Supplement to the Orange Book is published on the first day of the next month. All the information listed on this screen is also available by using the other Orange Book search methods, such as searching by Proprietary Name.
  • Patents will remain available in the Orange Book even when they are no longer listed as NEW additions or NEW changes.
Additional Information about Patents
  • Patent information is published on or after the submission date as defined in 21 CFR 314.53(d)(5).
  • Patent listings published prior to August 18, 2003, only identify method-of-use claims. The listed patents may include drug substance and/or drug product claims that are not indicated in the listing.
  • As of December 5, 2016, an NDA holder submitting information on a patent that claims both the drug substance and the drug product (and is eligible for listing on either basis) is required only to specify that it claims either the drug substance or the drug product. Orange Book users should not rely on an Orange Book patent listing, regardless of when first published, to determine the range of patent claims that may be asserted by an NDA holder or patent owner.
Appl No Active Ingredient Proprietary Name Dosage Form Route Strength Patent No Patent Expire Date Drug Substance Drug Product Patent Use Code Delist Requested Mkt. Status Submission Date
Appl No Active Ingredient Proprietary Name Dosage Form Route Strength Patent No Patent Expire Date Drug Substance Drug Product Patent Use Code Delist Requested Mkt. Status Submission Date
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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