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.
145 records returned
| Appl No | Active Ingredient | Proprietary Name | Dosage Form | Route | Strength | Patent No | Patent Expiration Date | Drug Substance Claim | Drug Product Claim | Patent Use Code | Delist Requested | Mkt. Status |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Appl No | Active Ingredient | Proprietary Name | Dosage Form | Route | Strength | Patent No | Patent Expiration Date | Drug Substance Claim | Drug Product Claim | Patent Use Code | Delist Requested | Mkt. Status |
| N019430 | EPINEPHRINE | EPIPEN | INJECTABLE | INTRAMUSCULAR, SUBCUTANEOUS | 0.3MG/DELIVERY | 9586010 | Sep 11, 2025 | DP | RX | |||
| N019430 | EPINEPHRINE | EPIPEN JR. | INJECTABLE | INTRAMUSCULAR, SUBCUTANEOUS | 0.15MG/DELIVERY | 9586010 | Sep 11, 2025 | DP | RX | |||
| N020986 | INSULIN ASPART RECOMBINANT | NOVOLOG FLEXTOUCH | INJECTABLE | SUBCUTANEOUS | 300 UNITS/3ML (100 UNITS/ML) | RE46363 | Aug 3, 2026 | DP | RX | |||
| N021148 | SOMATROPIN RECOMBINANT | NORDITROPIN FLEXPRO | INJECTABLE | INJECTION | 5MG/1.5ML | RE46363 | Aug 3, 2026 | DP | RX | |||
| N021148 | SOMATROPIN RECOMBINANT | NORDITROPIN FLEXPRO | INJECTABLE | INJECTION | 10MG/1.5ML | RE46363 | Aug 3, 2026 | DP | RX | |||
| N021148 | SOMATROPIN RECOMBINANT | NORDITROPIN FLEXPRO | INJECTABLE | INJECTION | 15MG/1.5ML | RE46363 | Aug 3, 2026 | DP | RX | |||
| N021148 | SOMATROPIN RECOMBINANT | NORDITROPIN FLEXPRO | INJECTABLE | INJECTION | 30MG/3ML | RE46363 | Aug 3, 2026 | DP | RX | |||
| N021536 | INSULIN DETEMIR RECOMBINANT | LEVEMIR FLEXTOUCH | INJECTABLE | SUBCUTANEOUS | 300 UNITS/3ML (100 UNITS/ML) | RE46363 | Aug 3, 2026 | DP | RX | |||
| N021936 | TIOTROPIUM BROMIDE | SPIRIVA RESPIMAT | SPRAY, METERED | INHALATION | EQ 0.00125MG BASE/INH | 5964416 | Oct 4, 2016 | DP | RX | |||
| N021936 | TIOTROPIUM BROMIDE | SPIRIVA RESPIMAT | SPRAY, METERED | INHALATION | EQ 0.00125MG BASE/INH | 6453795 | Dec 5, 2016 | DP | RX | |||
| N021936 | TIOTROPIUM BROMIDE | SPIRIVA RESPIMAT | SPRAY, METERED | INHALATION | EQ 0.00125MG BASE/INH | 6726124 | Oct 4, 2016 | DP | RX | |||
| N021936 | TIOTROPIUM BROMIDE | SPIRIVA RESPIMAT | SPRAY, METERED | INHALATION | EQ 0.00125MG BASE/INH | 7104470 | Oct 4, 2016 | DP | RX | |||
| N022266 | FENTANYL CITRATE | ONSOLIS | FILM | BUCCAL | EQ 0.2MG BASE | 9597288 | Jul 23, 2027 | DP | U-767 | DISCN | ||
| N022266 | FENTANYL CITRATE | ONSOLIS | FILM | BUCCAL | EQ 0.4MG BASE | 9597288 | Jul 23, 2027 | DP | U-767 | DISCN | ||
| N022266 | FENTANYL CITRATE | ONSOLIS | FILM | BUCCAL | EQ 0.6MG BASE | 9597288 | Jul 23, 2027 | DP | U-767 | DISCN | ||
| N022266 | FENTANYL CITRATE | ONSOLIS | FILM | BUCCAL | EQ 0.8MG BASE | 9597288 | Jul 23, 2027 | DP | U-767 | DISCN | ||
| N022266 | FENTANYL CITRATE | ONSOLIS | FILM | BUCCAL | EQ 1.2MG BASE | 9597288 | Jul 23, 2027 | DP | U-767 | DISCN | ||
| N022450 | ACETAMINOPHEN | OFIRMEV | SOLUTION | IV (INFUSION) | 1GM/100ML (10MG/ML) | 9610265 | Nov 13, 2028 | U-2000 | RX | |||
| N200327 | CEFTAROLINE FOSAMIL | TEFLARO | POWDER | IV (INFUSION) | 400MG/VIAL | 9629861 | Sep 21, 2030 | DP | RX | |||
| N200327 | CEFTAROLINE FOSAMIL | TEFLARO | POWDER | IV (INFUSION) | 600MG/VIAL | 9629861 | Sep 21, 2030 | DP | RX | |||
| N200678 | METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE | KOMBIGLYZE XR | TABLET, EXTENDED RELEASE | ORAL | 1GM;EQ 5MG BASE | 9339472 | Jul 13, 2025 | DP | RX | |||
| N200678 | METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE | KOMBIGLYZE XR | TABLET, EXTENDED RELEASE | ORAL | 1GM;EQ 2.5MG BASE | 9339472 | Jul 13, 2025 | DP | RX | |||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 25MG | 8298576 | Apr 4, 2028 | DP | U-106 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 25MG | 8298576 | Apr 4, 2028 | DP | U-1992 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 50MG | 8298576 | Apr 4, 2028 | DP | U-106 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 50MG | 8298576 | Apr 4, 2028 | DP | U-1992 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 100MG | 8298576 | Apr 4, 2028 | DP | U-106 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 100MG | 8298576 | Apr 4, 2028 | DP | U-1992 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 200MG | 8298576 | Apr 4, 2028 | DP | U-106 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 200MG | 8298576 | Apr 4, 2028 | DP | U-1992 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 25MG | 8298580 | Nov 16, 2027 | DP | U-106 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 25MG | 8298580 | Nov 16, 2027 | DP | U-1992 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 50MG | 8298580 | Nov 16, 2027 | DP | U-106 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 50MG | 8298580 | Nov 16, 2027 | DP | U-1992 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 100MG | 8298580 | Nov 16, 2027 | DP | U-106 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 100MG | 8298580 | Nov 16, 2027 | DP | U-1992 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 200MG | 8298580 | Nov 16, 2027 | DP | U-106 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 200MG | 8298580 | Nov 16, 2027 | DP | U-1992 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 25MG | 8663683 | Nov 16, 2027 | DP | U-106 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 25MG | 8663683 | Nov 16, 2027 | DP | U-1992 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 50MG | 8663683 | Nov 16, 2027 | DP | U-106 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 50MG | 8663683 | Nov 16, 2027 | DP | U-1992 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 100MG | 8663683 | Nov 16, 2027 | DP | U-106 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 100MG | 8663683 | Nov 16, 2027 | DP | U-1992 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 200MG | 8663683 | Nov 16, 2027 | DP | U-106 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 200MG | 8663683 | Nov 16, 2027 | DP | U-1992 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 25MG | 8877248 | Nov 16, 2027 | DP | U-106 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 25MG | 8877248 | Nov 16, 2027 | DP | U-1992 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 50MG | 8877248 | Nov 16, 2027 | DP | U-106 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 50MG | 8877248 | Nov 16, 2027 | DP | U-1992 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 100MG | 8877248 | Nov 16, 2027 | DP | U-106 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 100MG | 8877248 | Nov 16, 2027 | DP | U-1992 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 200MG | 8877248 | Nov 16, 2027 | DP | U-106 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 200MG | 8877248 | Nov 16, 2027 | DP | U-1992 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 25MG | 8889191 | Nov 16, 2027 | U-106 | RX | |||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 25MG | 8889191 | Nov 16, 2027 | U-1992 | RX | |||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 50MG | 8889191 | Nov 16, 2027 | U-106 | RX | |||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 50MG | 8889191 | Nov 16, 2027 | U-1992 | RX | |||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 100MG | 8889191 | Nov 16, 2027 | U-106 | RX | |||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 100MG | 8889191 | Nov 16, 2027 | U-1992 | RX | |||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 200MG | 8889191 | Nov 16, 2027 | U-106 | RX | |||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 200MG | 8889191 | Nov 16, 2027 | U-1992 | RX | |||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 25MG | 8992989 | Nov 16, 2027 | DP | U-1675 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 25MG | 8992989 | Nov 16, 2027 | DP | U-1992 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 50MG | 8992989 | Nov 16, 2027 | DP | U-1675 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 50MG | 8992989 | Nov 16, 2027 | DP | U-1992 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 100MG | 8992989 | Nov 16, 2027 | DP | U-1675 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 100MG | 8992989 | Nov 16, 2027 | DP | U-1992 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 200MG | 8992989 | Nov 16, 2027 | DP | U-1675 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 200MG | 8992989 | Nov 16, 2027 | DP | U-1992 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 25MG | 9549940 | Nov 16, 2027 | DP | U-1675 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 25MG | 9549940 | Nov 16, 2027 | DP | U-1992 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 50MG | 9549940 | Nov 16, 2027 | DP | U-1675 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 50MG | 9549940 | Nov 16, 2027 | DP | U-1992 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 100MG | 9549940 | Nov 16, 2027 | DP | U-1675 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 100MG | 9549940 | Nov 16, 2027 | DP | U-1992 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 200MG | 9549940 | Nov 16, 2027 | DP | U-1675 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 200MG | 9549940 | Nov 16, 2027 | DP | U-1992 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 25MG | 9555004 | Nov 16, 2027 | DP | U-1675 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 25MG | 9555004 | Nov 16, 2027 | DP | U-1992 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 50MG | 9555004 | Nov 16, 2027 | DP | U-1675 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 50MG | 9555004 | Nov 16, 2027 | DP | U-1992 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 100MG | 9555004 | Nov 16, 2027 | DP | U-1675 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 100MG | 9555004 | Nov 16, 2027 | DP | U-1992 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 200MG | 9555004 | Nov 16, 2027 | DP | U-1675 | RX | ||
| N201635 | TOPIRAMATE | TROKENDI XR | CAPSULE, EXTENDED RELEASE | ORAL | 200MG | 9555004 | Nov 16, 2027 | DP | U-1992 | RX | ||
| N202788 | FENTANYL | SUBSYS | SPRAY | SUBLINGUAL | 0.1MG | 9289387 | Jan 25, 2027 | DP | U-55 | RX | ||
| N202788 | FENTANYL | SUBSYS | SPRAY | SUBLINGUAL | 0.2MG | 9289387 | Jan 25, 2027 | DP | U-55 | RX | ||
| N202788 | FENTANYL | SUBSYS | SPRAY | SUBLINGUAL | 0.4MG | 9289387 | Jan 25, 2027 | DP | U-55 | RX | ||
| N202788 | FENTANYL | SUBSYS | SPRAY | SUBLINGUAL | 0.6MG | 9289387 | Jan 25, 2027 | DP | U-55 | RX | ||
| N202788 | FENTANYL | SUBSYS | SPRAY | SUBLINGUAL | 0.8MG | 9289387 | Jan 25, 2027 | DP | U-55 | RX | ||
| N202788 | FENTANYL | SUBSYS | SPRAY | SUBLINGUAL | 1.2MG | 9289387 | Jan 25, 2027 | DP | U-55 | RX | ||
| N202788 | FENTANYL | SUBSYS | SPRAY | SUBLINGUAL | 1.6MG | 9289387 | Jan 25, 2027 | DP | U-55 | RX | ||
| N202788 | FENTANYL | SUBSYS | SPRAY | SUBLINGUAL | 0.1MG | 9642797 | Jan 25, 2027 | DP | U-55 | RX | ||
| N202788 | FENTANYL | SUBSYS | SPRAY | SUBLINGUAL | 0.2MG | 9642797 | Jan 25, 2027 | DP | U-55 | RX | ||
| N202788 | FENTANYL | SUBSYS | SPRAY | SUBLINGUAL | 0.4MG | 9642797 | Jan 25, 2027 | DP | U-55 | RX | ||
| N202788 | FENTANYL | SUBSYS | SPRAY | SUBLINGUAL | 0.6MG | 9642797 | Jan 25, 2027 | DP | U-55 | RX | ||
| N202788 | FENTANYL | SUBSYS | SPRAY | SUBLINGUAL | 0.8MG | 9642797 | Jan 25, 2027 | DP | U-55 | RX | ||
| N202788 | FENTANYL | SUBSYS | SPRAY | SUBLINGUAL | 1.2MG | 9642797 | Jan 25, 2027 | DP | U-55 | RX | ||
| N202788 | FENTANYL | SUBSYS | SPRAY | SUBLINGUAL | 1.6MG | 9642797 | Jan 25, 2027 | DP | U-55 | RX | ||
| N202788 | FENTANYL | SUBSYS | SPRAY | SUBLINGUAL | 0.1MG | 9642844 | Jan 25, 2027 | DP | RX | |||
| N202788 | FENTANYL | SUBSYS | SPRAY | SUBLINGUAL | 0.2MG | 9642844 | Jan 25, 2027 | DP | RX | |||
| N202788 | FENTANYL | SUBSYS | SPRAY | SUBLINGUAL | 0.4MG | 9642844 | Jan 25, 2027 | DP | RX | |||
| N202788 | FENTANYL | SUBSYS | SPRAY | SUBLINGUAL | 0.6MG | 9642844 | Jan 25, 2027 | DP | RX | |||
| N202788 | FENTANYL | SUBSYS | SPRAY | SUBLINGUAL | 0.8MG | 9642844 | Jan 25, 2027 | DP | RX | |||
| N202788 | FENTANYL | SUBSYS | SPRAY | SUBLINGUAL | 1.2MG | 9642844 | Jan 25, 2027 | DP | RX | |||
| N202788 | FENTANYL | SUBSYS | SPRAY | SUBLINGUAL | 1.6MG | 9642844 | Jan 25, 2027 | DP | RX | |||
| N203313 | INSULIN ASPART; INSULIN DEGLUDEC | RYZODEG 70/30 | SOLUTION | SUBCUTANEOUS | 90 UNITS/3ML;210 UNITS/3ML (30 UNITS/ML;70 UNITS/ML) | RE46363 | Aug 3, 2026 | DP | RX | |||
| N203314 | INSULIN DEGLUDEC | TRESIBA | SOLUTION | SUBCUTANEOUS | 300 UNITS/3ML (100 UNITS/ML) | RE46363 | Aug 3, 2026 | DP | RX | |||
| N203314 | INSULIN DEGLUDEC | TRESIBA | SOLUTION | SUBCUTANEOUS | 600 UNITS/3ML (200 UNITS/ML) | RE46363 | Aug 3, 2026 | DP | RX | |||
| N204485 | VASOPRESSIN | VASOSTRICT | SOLUTION | IV (INFUSION) | 20UNITS/ML (20UNITS/ML) | 9375478 | Jan 30, 2035 | U-1857 | DISCN | |||
| N204485 | VASOPRESSIN | VASOSTRICT | SOLUTION | IV (INFUSION) | 20UNITS/ML (20UNITS/ML) | 9375478 | Jan 30, 2035 | U-1857 | RX | |||
| N206030 | CARBAMAZEPINE | CARNEXIV | SOLUTION | IV (INFUSION) | 200MG/20ML (10MG/ML) | 9629797 | Nov 10, 2028 | U-2004 | RX | |||
| N206030 | CARBAMAZEPINE | CARNEXIV | SOLUTION | IV (INFUSION) | 200MG/20ML (10MG/ML) | 9629797 | Nov 10, 2028 | U-2005 | RX | |||
| N206030 | CARBAMAZEPINE | CARNEXIV | SOLUTION | IV (INFUSION) | 200MG/20ML (10MG/ML) | 9629797 | Nov 10, 2028 | U-2006 | RX | |||
| N206110 | CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | POWDER | IV (INFUSION) | 50MG/VIAL | 9636407 | Dec 21, 2032 | DP | RX | |||
| N206110 | CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | POWDER | IV (INFUSION) | 70MG/VIAL | 9636407 | Dec 21, 2032 | DP | RX | |||
| N206321 | LIRAGLUTIDE RECOMBINANT | SAXENDA | SOLUTION | SUBCUTANEOUS | 18MG/3ML (6MG/ML) | RE46363 | Aug 3, 2026 | DP | RX | |||
| N206756 | OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE | STIOLTO RESPIMAT | SPRAY, METERED | INHALATION | EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH | 6149054 | Dec 19, 2016 | DP | RX | |||
| N206756 | OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE | STIOLTO RESPIMAT | SPRAY, METERED | INHALATION | EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH | 6149054*PED | Jun 19, 2017 | RX | ||||
| N206756 | OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE | STIOLTO RESPIMAT | SPRAY, METERED | INHALATION | EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH | 6846413 | Aug 28, 2018 | DP | RX | |||
| N206756 | OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE | STIOLTO RESPIMAT | SPRAY, METERED | INHALATION | EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH | 6846413*PED | Feb 28, 2019 | RX | ||||
| N206756 | OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE | STIOLTO RESPIMAT | SPRAY, METERED | INHALATION | EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH | 6977042 | Aug 28, 2018 | DP | RX | |||
| N206756 | OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE | STIOLTO RESPIMAT | SPRAY, METERED | INHALATION | EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH | 6977042*PED | Feb 28, 2019 | RX | ||||
| N206756 | OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE | STIOLTO RESPIMAT | SPRAY, METERED | INHALATION | EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH | 6988496 | Feb 23, 2020 | DP | RX | |||
| N206756 | OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE | STIOLTO RESPIMAT | SPRAY, METERED | INHALATION | EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH | 6988496*PED | Aug 23, 2020 | RX | ||||
| N206756 | OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE | STIOLTO RESPIMAT | SPRAY, METERED | INHALATION | EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH | 7284474 | Aug 26, 2024 | DP | RX | |||
| N206756 | OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE | STIOLTO RESPIMAT | SPRAY, METERED | INHALATION | EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH | 7284474*PED | Feb 26, 2025 | RX | ||||
| N206756 | OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE | STIOLTO RESPIMAT | SPRAY, METERED | INHALATION | EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH | 7396341 | Oct 10, 2026 | DP | RX | |||
| N206756 | OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE | STIOLTO RESPIMAT | SPRAY, METERED | INHALATION | EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH | 7396341*PED | Apr 10, 2027 | RX | ||||
| N206756 | OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE | STIOLTO RESPIMAT | SPRAY, METERED | INHALATION | EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH | 7802568 | Feb 26, 2019 | DP | RX | |||
| N206756 | OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE | STIOLTO RESPIMAT | SPRAY, METERED | INHALATION | EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH | 7802568*PED | Aug 26, 2019 | RX | ||||
| N206756 | OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE | STIOLTO RESPIMAT | SPRAY, METERED | INHALATION | EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH | 7837235 | Mar 13, 2028 | DP | RX | |||
| N206756 | OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE | STIOLTO RESPIMAT | SPRAY, METERED | INHALATION | EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH | 7837235*PED | Sep 13, 2028 | RX | ||||
| N207233 | MELOXICAM | VIVLODEX | CAPSULE | ORAL | 5MG | 9649318 | Mar 31, 2035 | DP | RX | |||
| N207233 | MELOXICAM | VIVLODEX | CAPSULE | ORAL | 10MG | 9649318 | Mar 31, 2035 | DP | RX | |||
| N207917 | ADAPALENE; BENZOYL PEROXIDE | EPIDUO FORTE | GEL | TOPICAL | 0.3%;2.5% | 8445543 | Dec 23, 2022 | U-1078 | RX | |||
| N207997 | MIDOSTAURIN | RYDAPT | CAPSULE | ORAL | 25MG | 7973031 | Oct 17, 2024 | U-2007 | RX | |||
| N207997 | MIDOSTAURIN | RYDAPT | CAPSULE | ORAL | 25MG | 8222244 | Oct 29, 2022 | U-2007 | RX | |||
| N207997 | MIDOSTAURIN | RYDAPT | CAPSULE | ORAL | 25MG | 8575146 | Dec 2, 2030 | U-2008 | RX | |||
| N208400 | METHOTREXATE SODIUM | XATMEP | SOLUTION | ORAL | EQ 2.5MG BASE/ML | 9259427 | Jan 2, 2033 | DP | RX | |||
| N208583 | INSULIN DEGLUDEC; LIRAGLUTIDE | XULTOPHY 100/3.6 | SOLUTION | SUBCUTANEOUS | 300 UNITS/3ML;10.8MG/3ML (100 UNITS/ML;3.6MG/ML) | RE46363 | Aug 3, 2026 | DP | RX | |||
| N209777 | OXYCODONE HYDROCHLORIDE | ROXYBOND | TABLET | ORAL | 5MG | 7955619 | Aug 12, 2028 | DP | RX | |||
| N209777 | OXYCODONE HYDROCHLORIDE | ROXYBOND | TABLET | ORAL | 15MG | 7955619 | Aug 12, 2028 | DP | RX | |||
| N209777 | OXYCODONE HYDROCHLORIDE | ROXYBOND | TABLET | ORAL | 30MG | 7955619 | Aug 12, 2028 | DP | RX |
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