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 |
N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 150MG,N/A;150MG, 100MG | 10058546 | 07/15/2033 |
U-3022
TREATMENT OF CF IN PATIENTS 12 YEARS AND OLDER WHO HAVE A F508DEL OR G551D CFTR MUTATION AND A 2ND MUTATION SELECTED FROM R117H, A455E, 2789+5G->A, & 3849+10KBC->T, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 10058546
|
RX | 09/21/2018 | |||
N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 150MG,N/A;150MG, 100MG | 10058546 | 07/15/2033 |
U-3023
TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE A F508DEL OR G551D CFTR MUTATION AND A 2ND MUTATION SELECTED FROM R117H, A455E, 2789+5G->A, AND 3849+10KBC->T, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 10058546
|
RX | 09/21/2018 | |||
N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 150MG,N/A;150MG, 100MG | 10058546 | 07/15/2033 |
U-2399
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 12 YEARS AND OLDER, WITH A F508DEL OR G551D CFTR GENE MUTATION AND A A455E, 2789+5G->A, OR 3849+10KBC->T MUTATION, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF U.S PATENT 10058546
|
RX | 09/21/2018 | |||
N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 150MG,N/A;150MG, 100MG | 10058546 | 07/15/2033 |
U-2572
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 6 YEARS AND OLDER, WITH A F508DEL OR G551D CFTR GENE MUTATION AND A A455E, 2789+5G->, OR 3849+10KBC->T MUTATION, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF U.S. PATENT 10058546
|
RX | 09/21/2018 | |||
N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 10058546 | 07/15/2033 |
U-3022
TREATMENT OF CF IN PATIENTS 12 YEARS AND OLDER WHO HAVE A F508DEL OR G551D CFTR MUTATION AND A 2ND MUTATION SELECTED FROM R117H, A455E, 2789+5G->A, & 3849+10KBC->T, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 10058546
|
RX | 07/17/2019 | |||
N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 10058546 | 07/15/2033 |
U-3023
TREATMENT OF CF IN PATIENTS 6 YEARS AND OLDER WHO HAVE A F508DEL OR G551D CFTR MUTATION AND A 2ND MUTATION SELECTED FROM R117H, A455E, 2789+5G->A, AND 3849+10KBC->T, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF US 10058546
|
RX | 07/17/2019 | |||
N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 10058546 | 07/15/2033 |
U-2399
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 12 YEARS AND OLDER, WITH A F508DEL OR G551D CFTR GENE MUTATION AND A A455E, 2789+5G->A, OR 3849+10KBC->T MUTATION, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF U.S PATENT 10058546
|
RX | 07/17/2019 | |||
N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 10058546 | 07/15/2033 |
U-2572
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS 6 YEARS AND OLDER, WITH A F508DEL OR G551D CFTR GENE MUTATION AND A A455E, 2789+5G->, OR 3849+10KBC->T MUTATION, COMPRISING CONCURRENT COADMINISTRATION OF THE COMPOSITIONS OF CLAIM 1 OF U.S. PATENT 10058546
|
RX | 07/17/2019 | |||
N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 150MG,N/A;150MG, 100MG | 10081621 | 03/25/2031 | DP |
U-3024
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR WHO HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,081,621
|
RX | 10/25/2018 | ||
N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 150MG,N/A;150MG, 100MG | 10081621 | 03/25/2031 | DP |
U-3025
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR WHO HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,081,621
|
RX | 10/25/2018 | ||
N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 150MG,N/A;150MG, 100MG | 10081621 | 03/25/2031 | DP |
U-2420
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGES 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR ONE F508DEL MUTATION AND A CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,081,621
|
RX | 10/25/2018 | ||
N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 150MG,N/A;150MG, 100MG | 10081621 | 03/25/2031 | DP |
U-2571
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGES 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR ONE F508DEL MUTATION AND A CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,081,621
|
RX | 10/25/2018 | ||
N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 10081621 | 03/25/2031 | DP |
U-3024
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR WHO HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,081,621
|
RX | 07/17/2019 | ||
N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 10081621 | 03/25/2031 | DP |
U-3025
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR WHO HAVE AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,081,621
|
RX | 07/17/2019 | ||
N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 10081621 | 03/25/2031 | DP |
U-2420
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGES 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR ONE F508DEL MUTATION AND A CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,081,621
|
RX | 07/17/2019 | ||
N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 10081621 | 03/25/2031 | DP |
U-2571
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGES 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR ONE F508DEL MUTATION AND A CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,081,621
|
RX | 07/17/2019 | ||
N212273 | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | TRIKAFTA (COPACKAGED) | TABLET, TABLET | ORAL | 100MG,75MG,50MG;N/A,150MG,N/A | 10081621 | 03/25/2031 | DP |
U-3032
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621
|
RX | 11/14/2019 | ||
N212273 | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | TRIKAFTA (COPACKAGED) | TABLET, TABLET | ORAL | 100MG,75MG,50MG;N/A,150MG,N/A | 10081621 | 03/25/2031 | DP |
U-2652
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH A COMPOSITION ACCORDING TO CLAIM 1 OF US 10081621
|
RX | 11/14/2019 | ||
N202860 | NITRIC OXIDE | GENOSYL | GAS | INHALATION | 800PPM | 10124142 | 08/18/2025 |
U-3037
A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
|
RX | 01/15/2021 | |||
N208065 | OSIMERTINIB MESYLATE | TAGRISSO | TABLET | ORAL | EQ 40MG BASE | 10183020 | 01/02/2035 | DP |
U-3016
ADJUVANT THERAPY AFTER TUMOR RESECTION IN PATIENTS WITH NON-SMALL CELL LUNG CANCER(NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19DELETIONS OR EXON 21 L858R MUTATIONS
|
RX | 02/12/2019 | ||
N208065 | OSIMERTINIB MESYLATE | TAGRISSO | TABLET | ORAL | EQ 40MG BASE | 10183020 | 01/02/2035 | DP |
U-1777
TREATMENT OF PATIENTS WITH METASTATIC EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) T790M MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC), WHO HAVE PROGRESSED ON OR AFTER EGFR TKI THERAPY
|
RX | 02/12/2019 | ||
N208065 | OSIMERTINIB MESYLATE | TAGRISSO | TABLET | ORAL | EQ 40MG BASE | 10183020 | 01/02/2035 | DP |
U-2289
TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21L858R MUTATIONS
|
RX | 02/12/2019 | ||
N208065 | OSIMERTINIB MESYLATE | TAGRISSO | TABLET | ORAL | EQ 80MG BASE | 10183020 | 01/02/2035 | DP |
U-3016
ADJUVANT THERAPY AFTER TUMOR RESECTION IN PATIENTS WITH NON-SMALL CELL LUNG CANCER(NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19DELETIONS OR EXON 21 L858R MUTATIONS
|
RX | 02/12/2019 | ||
N208065 | OSIMERTINIB MESYLATE | TAGRISSO | TABLET | ORAL | EQ 80MG BASE | 10183020 | 01/02/2035 | DP |
U-1777
TREATMENT OF PATIENTS WITH METASTATIC EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) T790M MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC), WHO HAVE PROGRESSED ON OR AFTER EGFR TKI THERAPY
|
RX | 02/12/2019 | ||
N208065 | OSIMERTINIB MESYLATE | TAGRISSO | TABLET | ORAL | EQ 80MG BASE | 10183020 | 01/02/2035 | DP |
U-2289
TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21L858R MUTATIONS
|
RX | 02/12/2019 | ||
N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 150MG,N/A;150MG, 100MG | 10206877 | 04/14/2035 | DP |
U-3026
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,206,877
|
RX | 03/20/2019 | ||
N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 150MG,N/A;150MG, 100MG | 10206877 | 04/14/2035 | DP |
U-3027
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,206,877
|
RX | 03/20/2019 | ||
N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 150MG,N/A;150MG, 100MG | 10206877 | 04/14/2035 | DP |
U-2498
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGES 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR ONE F508DEL MUTATION AND A CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,206,877
|
RX | 03/20/2019 | ||
N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 150MG,N/A;150MG, 100MG | 10206877 | 04/14/2035 | DP |
U-2570
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGES 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR ONE F508DEL MUTATION AND A CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,206,877
|
RX | 03/20/2019 | ||
N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 10206877 | 04/14/2035 | DP |
U-3026
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,206,877
|
RX | 07/17/2019 | ||
N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 10206877 | 04/14/2035 | DP |
U-3027
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR AT LEAST ONE CFTR MUTATION THAT IS RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,206,877
|
RX | 07/17/2019 | ||
N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 10206877 | 04/14/2035 | DP |
U-2498
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGES 12 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR ONE F508DEL MUTATION AND A CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,206,877
|
RX | 07/17/2019 | ||
N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 10206877 | 04/14/2035 | DP |
U-2570
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGES 6 AND OLDER, WHO HAVE TWO COPIES OF THE F508DEL MUTATION OR ONE F508DEL MUTATION AND A CFTR MUTATION PREDICTED TO BE RESPONSIVE TO TEZACAFTOR/IVACAFTOR, WITH THE COMPOSITION OF CLAIM 1 OF US 10,206,877
|
RX | 07/17/2019 | ||
N212273 | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | TRIKAFTA (COPACKAGED) | TABLET, TABLET | ORAL | 100MG,75MG,50MG;N/A,150MG,N/A | 10239867 | 04/09/2027 | DS | DP |
U-3033
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH AN EFFECTIVE AMOUNT OF ELX, TEZ, AND IVA
|
RX | 11/14/2019 | |
N212273 | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | TRIKAFTA (COPACKAGED) | TABLET, TABLET | ORAL | 100MG,75MG,50MG;N/A,150MG,N/A | 10239867 | 04/09/2027 | DS | DP |
U-2653
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH AN EFFECTIVE AMOUNT OF ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
|
RX | 11/14/2019 | |
N213189 | TIRBANIBULIN | KLISYRI | OINTMENT | TOPICAL | 1% | 10323001 | 12/28/2027 | DP |
|
RX | 01/12/2021 | ||
N214621 | RELUGOLIX | ORGOVYX | TABLET | ORAL | 120MG | 10350170 | 02/25/2036 | DP |
|
RX | 01/14/2021 | ||
N214621 | RELUGOLIX | ORGOVYX | TABLET | ORAL | 120MG | 10449191 | 09/29/2037 |
U-3020
TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER
|
RX | 01/14/2021 | |||
N212306 | SELINEXOR | XPOVIO | TABLET | ORAL | 20MG | 10519139 | 08/14/2035 | DS | DP |
U-2855
XPOVIO IS INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL), NOT OTHERWISE SPECIFIED, INCLUDING DLBCL ARISING FROM FOLLICULAR LYMPHOMA, AFTER AT LEAST 2 LINES OF SYSTEMIC THERAPY
|
RX | 01/27/2020 | |
N212306 | SELINEXOR | XPOVIO | TABLET | ORAL | 20MG | 10519139 | 08/14/2035 | DS | DP |
U-3018
XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
|
RX | 01/27/2020 | |
N212306 | SELINEXOR | XPOVIO | TABLET | ORAL | 20MG | 10519139 | 08/14/2035 | DS | DP |
U-2584
XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES
|
RX | 01/27/2020 | |
N212306 | SELINEXOR | XPOVIO | TABLET | ORAL | 20MG | 10544108 | 07/26/2032 |
U-3018
XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
|
RX | 02/24/2020 | |||
N212306 | SELINEXOR | XPOVIO | TABLET | ORAL | 20MG | 10544108 | 07/26/2032 |
U-2584
XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES
|
RX | 02/24/2020 | |||
N213189 | TIRBANIBULIN | KLISYRI | OINTMENT | TOPICAL | 1% | 10617693 | 03/12/2038 |
U-3015
TOPICAL TREATMENT OF ACTINIC KERATOSIS OF THE FACE OR SCALP
|
RX | 01/12/2021 | |||
N213189 | TIRBANIBULIN | KLISYRI | OINTMENT | TOPICAL | 1% | 10669236 | 09/07/2038 | DS | DP |
|
RX | 01/12/2021 | |
N212273 | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | TRIKAFTA (COPACKAGED) | TABLET, TABLET | ORAL | 100MG,75MG,50MG;N/A,150MG,N/A | 10758534 | 10/06/2035 | DS | DP |
U-3028
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
|
RX | 09/22/2020 | |
N212273 | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | TRIKAFTA (COPACKAGED) | TABLET, TABLET | ORAL | 100MG,75MG,50MG;N/A,150MG,N/A | 10758534 | 10/06/2035 | DS | DP |
U-2645
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
|
RX | 09/22/2020 | |
N214621 | RELUGOLIX | ORGOVYX | TABLET | ORAL | 120MG | 10786501 | 09/29/2037 |
U-3020
TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER
|
RX | 01/14/2021 | |||
N212273 | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | TRIKAFTA (COPACKAGED) | TABLET, TABLET | ORAL | 100MG,75MG,50MG;N/A,150MG,N/A | 10793547 | 12/08/2037 | DS | DP |
U-3028
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
|
RX | 10/29/2020 | |
N212273 | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | TRIKAFTA (COPACKAGED) | TABLET, TABLET | ORAL | 100MG,75MG,50MG;N/A,150MG,N/A | 10793547 | 12/08/2037 | DS | DP |
U-2645
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
|
RX | 10/29/2020 | |
N202860 | NITRIC OXIDE | GENOSYL | GAS | INHALATION | 800PPM | 10814092 | 10/17/2025 |
U-3037
A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
|
RX | 01/15/2021 | |||
N202514 | TAFLUPROST | ZIOPTAN | SOLUTION/DROPS | OPHTHALMIC | 0.0015% | 10864159 | 05/28/2029 | DP |
U-778
REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION
|
RX | 01/08/2021 | ||
N021196 | SODIUM OXYBATE | XYREM | SOLUTION | ORAL | 0.5GM/ML | 10864181 | 03/15/2033 |
U-1532
METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS AND/OR CATAPLEXY IN NARCOLEPSY PATIENTS WITH SODIUM OXYBATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED.
|
RX | 01/13/2021 | |||
N212690 | CALCIUM OXYBATE; MAGNESIUM OXYBATE; POTASSIUM OXYBATE; SODIUM OXYBATE | XYWAV | SOLUTION | ORAL | 0.234GM/ML;0.096GM/ML;0.13GM/ML;0.04GM/ML | 10864181 | 03/15/2033 |
U-3017
METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS AND/OR CATAPLEXY IN NARCOLEPSY PATIENTS WITH A SALT OF GAMMA-HYDROXYBUTYRATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED
|
RX | 01/13/2021 | |||
N203567 | EFINACONAZOLE | JUBLIA | SOLUTION | TOPICAL | 10% | 10864274 | 10/02/2034 |
U-2720
ANTIMYCOTIC USES, SPECIFICALLY TREATMENT OF ONYCHOMYCOSIS; TOPICAL TREATMENT OF THE TOENAIL(S) DUE TO TRICHOPHYTON RUBRUM AND TRICHOPHYTON MENTAGROPHYTES
|
RX | 01/07/2021 | |||
N211243 | ESKETAMINE HYDROCHLORIDE | SPRAVATO | SPRAY | NASAL | EQ 28MG BASE | 10869844 | 09/10/2035 |
U-3035
TREATMENT OF DEPRESSIVE SYMPTOMS IN ADULTS WITH MDD WITH ACUTE SUICIDAL IDEATION OR BEHAVIOR BY NASALLY ADMINISTERING 56MG OR 84 MG OF ESKETAMINE 2X WEEKLY FOR 4 WEEKS IN CONJUNCTION WITH AN ORAL ANTIDEPRESSANT
|
RX | 01/15/2021 | |||
N211243 | ESKETAMINE HYDROCHLORIDE | SPRAVATO | SPRAY | NASAL | EQ 28MG BASE | 10869844 | 09/10/2035 |
U-3036
TREATMENT OF TRD IN ADULTS BY NASALLY ADMINISTERING 56MG OR 84MG OF ESKETAMINE 2X WEEKLY FOR 4 WEEKS DURING THE INDUCTION PHASE FOLLOWED BY A MAINTENANCE PHASE OF 56MG OR 84 MG WEEKLY OR 1X EVERY TWO WEEKS IN CONJUNCTION WITH AN ORAL ANTIDEPRESSANT
|
RX | 01/15/2021 | |||
N211243 | ESKETAMINE HYDROCHLORIDE | SPRAVATO | SPRAY | NASAL | EQ 28MG BASE | 10869844 | 09/10/2035 |
U-3034
TREATMENT OF TRD IN ADULTS BY NASALLY ADMINISTERING 56MG OR 84MG OF ESKETAMINE 2X WEEKLY FOR 4 WEEKS DURING THE INDUCTION PHASE IN CONJUNCTION WITH AN ORAL ANTIDEPRESSENT
|
RX | 01/15/2021 | |||
N208623 | MIGALASTAT HYDROCHLORIDE | GALAFOLD | CAPSULE | ORAL | EQ 123MG BASE | 10874655 | 05/30/2038 |
U-2371
THE TREATMENT OF FABRY PATIENTS
|
RX | 01/07/2021 | |||
N208623 | MIGALASTAT HYDROCHLORIDE | GALAFOLD | CAPSULE | ORAL | EQ 123MG BASE | 10874656 | 05/30/2038 |
U-2371
THE TREATMENT OF FABRY PATIENTS
|
RX | 01/07/2021 | |||
N208623 | MIGALASTAT HYDROCHLORIDE | GALAFOLD | CAPSULE | ORAL | EQ 123MG BASE | 10874657 | 05/30/2038 |
U-2371
THE TREATMENT OF FABRY PATIENTS
|
RX | 01/07/2021 | |||
N210875 | APOMORPHINE HYDROCHLORIDE | KYNMOBI | FILM | SUBLINGUAL | 15MG | 10888499 | 02/14/2022 | DP |
|
RX | 01/14/2021 | ||
N210875 | APOMORPHINE HYDROCHLORIDE | KYNMOBI | FILM | SUBLINGUAL | 25MG | 10888499 | 02/14/2022 | DP |
|
RX | 01/14/2021 | ||
N210875 | APOMORPHINE HYDROCHLORIDE | KYNMOBI | FILM | SUBLINGUAL | 10MG | 10888499 | 02/14/2022 | DP |
|
RX | 01/14/2021 | ||
N210875 | APOMORPHINE HYDROCHLORIDE | KYNMOBI | FILM | SUBLINGUAL | 20MG | 10888499 | 02/14/2022 | DP |
|
RX | 01/14/2021 | ||
N210875 | APOMORPHINE HYDROCHLORIDE | KYNMOBI | FILM | SUBLINGUAL | 30MG | 10888499 | 02/14/2022 | DP |
|
RX | 01/14/2021 | ||
N213189 | TIRBANIBULIN | KLISYRI | OINTMENT | TOPICAL | 1% | 7300931 | 02/06/2026 | DS | DP |
|
RX | 01/12/2021 | |
N214621 | RELUGOLIX | ORGOVYX | TABLET | ORAL | 120MG | 7300935 | 01/28/2024 | DS |
|
RX | 01/14/2021 | ||
N213189 | TIRBANIBULIN | KLISYRI | OINTMENT | TOPICAL | 1% | 7851470 | 02/02/2029 | DS | DP |
U-3015
TOPICAL TREATMENT OF ACTINIC KERATOSIS OF THE FACE OR SCALP
|
RX | 01/12/2021 | |
N202860 | NITRIC OXIDE | GENOSYL | GAS | INHALATION | 800PPM | 7947227 | 10/17/2026 |
U-3037
A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
|
RX | 01/15/2021 | |||
N202860 | NITRIC OXIDE | GENOSYL | GAS | INHALATION | 800PPM | 8057742 | 01/18/2026 |
U-3037
A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
|
RX | 01/15/2021 | |||
N214621 | RELUGOLIX | ORGOVYX | TABLET | ORAL | 120MG | 8058280 | 01/28/2024 | DS | DP |
|
RX | 01/14/2021 | |
N203469 | PONATINIB HYDROCHLORIDE | ICLUSIG | TABLET | ORAL | EQ 30MG BASE | 8114874 | 01/24/2027 | DS | DP |
|
RX | 06/09/2015 | |
N203469 | PONATINIB HYDROCHLORIDE | ICLUSIG | TABLET | ORAL | EQ 10MG BASE | 8114874 | 01/24/2027 | DS | DP |
|
RX | 01/14/2021 | |
N202860 | NITRIC OXIDE | GENOSYL | GAS | INHALATION | 800PPM | 8226916 | 08/18/2025 |
U-3037
A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
|
RX | 01/15/2021 | |||
N213189 | TIRBANIBULIN | KLISYRI | OINTMENT | TOPICAL | 1% | 8236799 | 12/28/2025 | DS | DP |
|
RX | 01/12/2021 | |
N212273 | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | TRIKAFTA (COPACKAGED) | TABLET, TABLET | ORAL | 100MG,75MG,50MG;N/A,150MG,N/A | 8324242 | 08/05/2027 |
U-3028
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
|
RX | 11/14/2019 | |||
N212273 | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | TRIKAFTA (COPACKAGED) | TABLET, TABLET | ORAL | 100MG,75MG,50MG;N/A,150MG,N/A | 8324242 | 08/05/2027 |
U-2645
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
|
RX | 11/14/2019 | |||
N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 150MG,N/A;150MG, 100MG | 8354427 | 07/06/2026 |
U-3021
TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 YEARS AND OLDER WHO HAVE A R117H MUTATION IN THE CFTR GENE
|
RX | 01/14/2021 | |||
N210491 | IVACAFTOR; IVACAFTOR, TEZACAFTOR | SYMDEKO (COPACKAGED) | TABLET, TABLET | ORAL | 75MG,N/A;75MG, 50MG | 8354427 | 07/06/2026 |
U-3021
TEZACAFTOR AND IVACAFTOR FOR THE TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGE 6 YEARS AND OLDER WHO HAVE A R117H MUTATION IN THE CFTR GENE
|
RX | 01/14/2021 | |||
N212273 | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | TRIKAFTA (COPACKAGED) | TABLET, TABLET | ORAL | 100MG,75MG,50MG;N/A,150MG,N/A | 8354427 | 07/06/2026 |
U-3029
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE A R117H MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
|
RX | 11/14/2019 | |||
N212273 | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | TRIKAFTA (COPACKAGED) | TABLET, TABLET | ORAL | 100MG,75MG,50MG;N/A,150MG,N/A | 8354427 | 07/06/2026 |
U-2646
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE ONE F508DEL MUTATION AND ONE R117H MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
|
RX | 11/14/2019 | |||
N212273 | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | TRIKAFTA (COPACKAGED) | TABLET, TABLET | ORAL | 100MG,75MG,50MG;N/A,150MG,N/A | 8415387 | 11/12/2027 |
U-3028
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
|
RX | 11/14/2019 | |||
N212273 | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | TRIKAFTA (COPACKAGED) | TABLET, TABLET | ORAL | 100MG,75MG,50MG;N/A,150MG,N/A | 8415387 | 11/12/2027 |
U-2645
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
|
RX | 11/14/2019 | |||
N212273 | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | TRIKAFTA (COPACKAGED) | TABLET, TABLET | ORAL | 100MG,75MG,50MG;N/A,150MG,N/A | 8598181 | 05/01/2027 |
U-3028
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
|
RX | 11/14/2019 | |||
N212273 | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | TRIKAFTA (COPACKAGED) | TABLET, TABLET | ORAL | 100MG,75MG,50MG;N/A,150MG,N/A | 8598181 | 05/01/2027 |
U-2645
TREATMENT OF CYSTIC FIBROSIS IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
|
RX | 11/14/2019 | |||
N202860 | NITRIC OXIDE | GENOSYL | GAS | INHALATION | 800PPM | 8607785 | 07/14/2030 | DP |
|
RX | 01/15/2021 | ||
N202860 | NITRIC OXIDE | GENOSYL | GAS | INHALATION | 800PPM | 8609028 | 08/18/2025 |
U-3037
A METHOD OF DELIVERING NITRIC OXIDE TO A PATIENT
|
RX | 01/15/2021 | |||
N212273 | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | TRIKAFTA (COPACKAGED) | TABLET, TABLET | ORAL | 100MG,75MG,50MG;N/A,150MG,N/A | 8629162 | 06/24/2025 |
U-3030
TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA WITH ELX, TEZ, AND IVA
|
RX | 11/14/2019 | |||
N212273 | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | TRIKAFTA (COPACKAGED) | TABLET, TABLET | ORAL | 100MG,75MG,50MG;N/A,150MG,N/A | 8629162 | 06/24/2025 |
U-2648
TREATMENT OF A MODERATE TO MILD CLINICAL PHENOTYPE OF CF IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE WITH ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR
|
RX | 11/14/2019 | |||
N214621 | RELUGOLIX | ORGOVYX | TABLET | ORAL | 120MG | 8735401 | 02/04/2024 |
U-3019
TREATMENT OF ADULT PATIENTS WITH ADVANCED PROSTATE CANCER THAT IS SEX-HORMONE-DEPENDENT
|
RX | 01/14/2021 | |||
N202860 | NITRIC OXIDE | GENOSYL | GAS | INHALATION | 800PPM | 8821801 | 08/18/2025 | DP |
|
RX | 01/15/2021 | ||
N202860 | NITRIC OXIDE | GENOSYL | GAS | INHALATION | 800PPM | 8944049 | 08/13/2029 | DP |
|
RX | 01/15/2021 | ||
N208065 | OSIMERTINIB MESYLATE | TAGRISSO | TABLET | ORAL | EQ 40MG BASE | 8946235 | 08/08/2032 | DS | DP |
U-3016
ADJUVANT THERAPY AFTER TUMOR RESECTION IN PATIENTS WITH NON-SMALL CELL LUNG CANCER(NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19DELETIONS OR EXON 21 L858R MUTATIONS
|
RX | 12/11/2015 | |
N208065 | OSIMERTINIB MESYLATE | TAGRISSO | TABLET | ORAL | EQ 40MG BASE | 8946235 | 08/08/2032 | DS | DP |
U-1777
TREATMENT OF PATIENTS WITH METASTATIC EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) T790M MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC), WHO HAVE PROGRESSED ON OR AFTER EGFR TKI THERAPY
|
RX | 12/11/2015 | |
N208065 | OSIMERTINIB MESYLATE | TAGRISSO | TABLET | ORAL | EQ 40MG BASE | 8946235 | 08/08/2032 | DS | DP |
U-2289
TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21L858R MUTATIONS
|
RX | 12/11/2015 | |
N208065 | OSIMERTINIB MESYLATE | TAGRISSO | TABLET | ORAL | EQ 80MG BASE | 8946235 | 08/08/2032 | DS | DP |
U-3016
ADJUVANT THERAPY AFTER TUMOR RESECTION IN PATIENTS WITH NON-SMALL CELL LUNG CANCER(NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19DELETIONS OR EXON 21 L858R MUTATIONS
|
RX | 12/11/2015 | |
N208065 | OSIMERTINIB MESYLATE | TAGRISSO | TABLET | ORAL | EQ 80MG BASE | 8946235 | 08/08/2032 | DS | DP |
U-1777
TREATMENT OF PATIENTS WITH METASTATIC EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) T790M MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC), WHO HAVE PROGRESSED ON OR AFTER EGFR TKI THERAPY
|
RX | 12/11/2015 | |
N208065 | OSIMERTINIB MESYLATE | TAGRISSO | TABLET | ORAL | EQ 80MG BASE | 8946235 | 08/08/2032 | DS | DP |
U-2289
TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21L858R MUTATIONS
|
RX | 12/11/2015 | |
N213189 | TIRBANIBULIN | KLISYRI | OINTMENT | TOPICAL | 1% | 8980890 | 12/28/2025 | DS | DP |
|
RX | 01/12/2021 | |
N203469 | PONATINIB HYDROCHLORIDE | ICLUSIG | TABLET | ORAL | EQ 10MG BASE | 9029533 | 12/22/2026 |
U-836
A METHOD FOR THE TREATMENT OF LEUKEMIAS
|
RX | 01/14/2021 | |||
N203469 | PONATINIB HYDROCHLORIDE | ICLUSIG | TABLET | ORAL | EQ 10MG BASE | 9029533 | 12/22/2026 |
U-1699
A METHOD FOR TREATING ACUTE LYMPHOBLASTIC LEUKEMIA
|
RX | 01/14/2021 | |||
N203469 | PONATINIB HYDROCHLORIDE | ICLUSIG | TABLET | ORAL | EQ 10MG BASE | 9029533 | 12/22/2026 |
U-1701
A METHOD FOR TREATING LEUKEMIA RESULTING FROM A MUTATION IN THE BCR-ABL KINASE DOMAIN
|
RX | 01/14/2021 | |||
N203469 | PONATINIB HYDROCHLORIDE | ICLUSIG | TABLET | ORAL | EQ 10MG BASE | 9029533 | 12/22/2026 |
U-1700
A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA
|
RX | 01/14/2021 | |||
N203469 | PONATINIB HYDROCHLORIDE | ICLUSIG | TABLET | ORAL | EQ 10MG BASE | 9029533 | 12/22/2026 |
U-1283
A METHOD OF TREATING CHRONIC MYELOGENOUS LEUKEMIA
|
RX | 01/14/2021 | |||
N212306 | SELINEXOR | XPOVIO | TABLET | ORAL | 20MG | 9079865 | 07/26/2032 |
U-2855
XPOVIO IS INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL), NOT OTHERWISE SPECIFIED, INCLUDING DLBCL ARISING FROM FOLLICULAR LYMPHOMA, AFTER AT LEAST 2 LINES OF SYSTEMIC THERAPY
|
RX | 07/31/2019 | |||
N212306 | SELINEXOR | XPOVIO | TABLET | ORAL | 20MG | 9079865 | 07/26/2032 |
U-3018
XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
|
RX | 07/31/2019 | |||
N212306 | SELINEXOR | XPOVIO | TABLET | ORAL | 20MG | 9079865 | 07/26/2032 |
U-2584
XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES
|
RX | 07/31/2019 | |||
N203469 | PONATINIB HYDROCHLORIDE | ICLUSIG | TABLET | ORAL | EQ 10MG BASE | 9493470 | 12/12/2033 | DS | DP |
U-1948
A METHOD FOR TREATING CHRONIC MYELOID LEUKEMIA
|
RX | 01/14/2021 | |
N203469 | PONATINIB HYDROCHLORIDE | ICLUSIG | TABLET | ORAL | EQ 10MG BASE | 9493470 | 12/12/2033 | DS | DP |
U-1700
A METHOD FOR TREATING PHILADELPHIA CHROMOSOME POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA
|
RX | 01/14/2021 | |
N202860 | NITRIC OXIDE | GENOSYL | GAS | INHALATION | 800PPM | 9522249 | 08/18/2025 | DP |
|
RX | 01/15/2021 | ||
N212273 | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | TRIKAFTA (COPACKAGED) | TABLET, TABLET | ORAL | 100MG,75MG,50MG;N/A,150MG,N/A | 9670163 | 12/28/2026 | DP |
U-3031
TREATMENT OF CF IN PATIENTS 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION OR A MUTATION IN THE CFTR GENE THAT IS RESPONSIVE BASED ON IN VITRO DATA USING A SOLID COMPOSITION COMPRISING ELX, TEZ, AMORPHOUS IVA, AND < ~30% CRYSTALLINE IVA
|
RX | 11/14/2019 | ||
N212273 | ELEXACAFTOR, IVACAFTOR, TEZACAFTOR; IVACAFTOR | TRIKAFTA (COPACKAGED) | TABLET, TABLET | ORAL | 100MG,75MG,50MG;N/A,150MG,N/A | 9670163 | 12/28/2026 | DP |
U-2650
TREATMENT OF CF IN PATIENTS AGED 12 YEARS AND OLDER WHO HAVE AT LEAST ONE F508DEL MUTATION IN THE CFTR GENE USING A SOLID COMPOSITION COMPRISING ELEXACAFTOR, TEZACAFTOR, AMORPHOUS IVACAFTOR, AND LESS THAN ABOUT 30% CRYSTALLINE IVACAFTOR
|
RX | 11/14/2019 | ||
N202860 | NITRIC OXIDE | GENOSYL | GAS | INHALATION | 800PPM | 9701538 | 01/28/2029 | DP |
|
RX | 01/15/2021 | ||
N208065 | OSIMERTINIB MESYLATE | TAGRISSO | TABLET | ORAL | EQ 40MG BASE | 9732058 | 07/25/2032 | DS | DP |
U-3016
ADJUVANT THERAPY AFTER TUMOR RESECTION IN PATIENTS WITH NON-SMALL CELL LUNG CANCER(NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19DELETIONS OR EXON 21 L858R MUTATIONS
|
RX | 08/29/2017 | |
N208065 | OSIMERTINIB MESYLATE | TAGRISSO | TABLET | ORAL | EQ 40MG BASE | 9732058 | 07/25/2032 | DS | DP |
U-1777
TREATMENT OF PATIENTS WITH METASTATIC EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) T790M MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC), WHO HAVE PROGRESSED ON OR AFTER EGFR TKI THERAPY
|
RX | 08/29/2017 | |
N208065 | OSIMERTINIB MESYLATE | TAGRISSO | TABLET | ORAL | EQ 40MG BASE | 9732058 | 07/25/2032 | DS | DP |
U-2289
TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21L858R MUTATIONS
|
RX | 08/29/2017 | |
N208065 | OSIMERTINIB MESYLATE | TAGRISSO | TABLET | ORAL | EQ 80MG BASE | 9732058 | 07/25/2032 | DS | DP |
U-3016
ADJUVANT THERAPY AFTER TUMOR RESECTION IN PATIENTS WITH NON-SMALL CELL LUNG CANCER(NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19DELETIONS OR EXON 21 L858R MUTATIONS
|
RX | 08/29/2017 | |
N208065 | OSIMERTINIB MESYLATE | TAGRISSO | TABLET | ORAL | EQ 80MG BASE | 9732058 | 07/25/2032 | DS | DP |
U-1777
TREATMENT OF PATIENTS WITH METASTATIC EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) T790M MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC), WHO HAVE PROGRESSED ON OR AFTER EGFR TKI THERAPY
|
RX | 08/29/2017 | |
N208065 | OSIMERTINIB MESYLATE | TAGRISSO | TABLET | ORAL | EQ 80MG BASE | 9732058 | 07/25/2032 | DS | DP |
U-2289
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