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
N215515 VUTRISIRAN AMVUTTRA SOLUTION SUBCUTANEOUS 25MG/0.5ML (25MG/0.5ML) 10131907 08/24/2028 DS DP
U-3396 AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
RX 07/13/2022
N203389 CYSTEAMINE BITARTRATE PROCYSBI CAPSULE, DELAYED RELEASE ORAL EQ 25MG BASE 10143665 08/16/2036
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
RX 12/20/2018
N203389 CYSTEAMINE BITARTRATE PROCYSBI CAPSULE, DELAYED RELEASE ORAL EQ 75MG BASE 10143665 08/16/2036
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
RX 12/20/2018
N213491 CYSTEAMINE BITARTRATE PROCYSBI GRANULE, DELAYED RELEASE ORAL EQ 75MG BASE/PACKET 10143665 08/16/2036
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
RX 03/13/2020
N213491 CYSTEAMINE BITARTRATE PROCYSBI GRANULE, DELAYED RELEASE ORAL EQ 300MG BASE/PACKET 10143665 08/16/2036
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
RX 03/13/2020
N203389 CYSTEAMINE BITARTRATE PROCYSBI CAPSULE, DELAYED RELEASE ORAL EQ 25MG BASE 10143665*PED 02/16/2037
RX
N203389 CYSTEAMINE BITARTRATE PROCYSBI CAPSULE, DELAYED RELEASE ORAL EQ 75MG BASE 10143665*PED 02/16/2037
RX
N213491 CYSTEAMINE BITARTRATE PROCYSBI GRANULE, DELAYED RELEASE ORAL EQ 75MG BASE/PACKET 10143665*PED 02/16/2037
RX
N213491 CYSTEAMINE BITARTRATE PROCYSBI GRANULE, DELAYED RELEASE ORAL EQ 300MG BASE/PACKET 10143665*PED 02/16/2037
RX
N216285 DROSPIRENONE DROSPIRENONE TABLET, CHEWABLE ORAL 3.5MG 10179140 06/28/2031
U-2553 PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE
RX 07/13/2022
N215515 VUTRISIRAN AMVUTTRA SOLUTION SUBCUTANEOUS 25MG/0.5ML (25MG/0.5ML) 10208307 07/28/2036 DS DP
U-3396 AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
RX 07/13/2022
N203389 CYSTEAMINE BITARTRATE PROCYSBI CAPSULE, DELAYED RELEASE ORAL EQ 25MG BASE 10328037 08/16/2036
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
RX 07/25/2019
N203389 CYSTEAMINE BITARTRATE PROCYSBI CAPSULE, DELAYED RELEASE ORAL EQ 75MG BASE 10328037 08/16/2036
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
RX 07/25/2019
N213491 CYSTEAMINE BITARTRATE PROCYSBI GRANULE, DELAYED RELEASE ORAL EQ 75MG BASE/PACKET 10328037 08/16/2036
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
RX 03/13/2020
N213491 CYSTEAMINE BITARTRATE PROCYSBI GRANULE, DELAYED RELEASE ORAL EQ 300MG BASE/PACKET 10328037 08/16/2036
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
RX 03/13/2020
N203389 CYSTEAMINE BITARTRATE PROCYSBI CAPSULE, DELAYED RELEASE ORAL EQ 25MG BASE 10328037*PED 02/16/2037
RX
N203389 CYSTEAMINE BITARTRATE PROCYSBI CAPSULE, DELAYED RELEASE ORAL EQ 75MG BASE 10328037*PED 02/16/2037
RX
N213491 CYSTEAMINE BITARTRATE PROCYSBI GRANULE, DELAYED RELEASE ORAL EQ 75MG BASE/PACKET 10328037*PED 02/16/2037
RX
N213491 CYSTEAMINE BITARTRATE PROCYSBI GRANULE, DELAYED RELEASE ORAL EQ 300MG BASE/PACKET 10328037*PED 02/16/2037
RX
N206192 COBIMETINIB FUMARATE COTELLIC TABLET ORAL EQ 20MG BASE 10478400 06/29/2036 DS DP
U-1776 METHOD OF USING COBIMETINIB FOR THE TREATMENT OF MELANOMA
RX 12/18/2019
N206192 COBIMETINIB FUMARATE COTELLIC TABLET ORAL EQ 20MG BASE 10478400*PED 12/29/2036
RX
N203389 CYSTEAMINE BITARTRATE PROCYSBI CAPSULE, DELAYED RELEASE ORAL EQ 25MG BASE 10548859 08/16/2036
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
RX 03/04/2020
N203389 CYSTEAMINE BITARTRATE PROCYSBI CAPSULE, DELAYED RELEASE ORAL EQ 75MG BASE 10548859 08/16/2036
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
RX 03/04/2020
N213491 CYSTEAMINE BITARTRATE PROCYSBI GRANULE, DELAYED RELEASE ORAL EQ 75MG BASE/PACKET 10548859 08/16/2036
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
RX 03/13/2020
N213491 CYSTEAMINE BITARTRATE PROCYSBI GRANULE, DELAYED RELEASE ORAL EQ 300MG BASE/PACKET 10548859 08/16/2036
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
RX 03/13/2020
N203389 CYSTEAMINE BITARTRATE PROCYSBI CAPSULE, DELAYED RELEASE ORAL EQ 25MG BASE 10548859*PED 02/16/2037
RX
N203389 CYSTEAMINE BITARTRATE PROCYSBI CAPSULE, DELAYED RELEASE ORAL EQ 75MG BASE 10548859*PED 02/16/2037
RX
N213491 CYSTEAMINE BITARTRATE PROCYSBI GRANULE, DELAYED RELEASE ORAL EQ 75MG BASE/PACKET 10548859*PED 02/16/2037
RX
N213491 CYSTEAMINE BITARTRATE PROCYSBI GRANULE, DELAYED RELEASE ORAL EQ 300MG BASE/PACKET 10548859*PED 02/16/2037
RX
N215515 VUTRISIRAN AMVUTTRA SOLUTION SUBCUTANEOUS 25MG/0.5ML (25MG/0.5ML) 10570391 11/16/2032 DS DP
U-3396 AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
RX 07/13/2022
N206192 COBIMETINIB FUMARATE COTELLIC TABLET ORAL EQ 20MG BASE 10590102 06/30/2036 DS DP
U-1776 METHOD OF USING COBIMETINIB FOR THE TREATMENT OF MELANOMA
RX 04/08/2020
N206192 COBIMETINIB FUMARATE COTELLIC TABLET ORAL EQ 20MG BASE 10590102*PED 12/30/2036
RX
N216285 DROSPIRENONE DROSPIRENONE TABLET, CHEWABLE ORAL 3.5MG 10603281 06/28/2031
U-2553 PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE
RX 07/13/2022
N215515 VUTRISIRAN AMVUTTRA SOLUTION SUBCUTANEOUS 25MG/0.5ML (25MG/0.5ML) 10612024 08/14/2035 DS DP
U-3396 AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
RX 07/13/2022
N215515 VUTRISIRAN AMVUTTRA SOLUTION SUBCUTANEOUS 25MG/0.5ML (25MG/0.5ML) 10683501 07/28/2036 DS DP
U-3396 AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
RX 07/13/2022
N215515 VUTRISIRAN AMVUTTRA SOLUTION SUBCUTANEOUS 25MG/0.5ML (25MG/0.5ML) 10806791 12/04/2028 DS
RX 07/13/2022
N216285 DROSPIRENONE DROSPIRENONE TABLET, CHEWABLE ORAL 3.5MG 10849857 06/28/2031 DP
U-2553 PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE
RX 07/13/2022
N202324 AXITINIB INLYTA TABLET ORAL 1MG 10869924 01/12/2037
U-3044 AXITINIB IN COMBINATION WITH AVELUMAB FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL CARCINOMA
RX 01/21/2021
N202324 AXITINIB INLYTA TABLET ORAL 5MG 10869924 01/12/2037
U-3044 AXITINIB IN COMBINATION WITH AVELUMAB FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH ADVANCED RENAL CELL CARCINOMA
RX 01/21/2021
N203389 CYSTEAMINE BITARTRATE PROCYSBI CAPSULE, DELAYED RELEASE ORAL EQ 25MG BASE 10905662 08/16/2036
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
RX 03/02/2021
N203389 CYSTEAMINE BITARTRATE PROCYSBI CAPSULE, DELAYED RELEASE ORAL EQ 75MG BASE 10905662 08/16/2036
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
RX 03/02/2021
N213491 CYSTEAMINE BITARTRATE PROCYSBI GRANULE, DELAYED RELEASE ORAL EQ 75MG BASE/PACKET 10905662 08/16/2036
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
RX 03/02/2021
N213491 CYSTEAMINE BITARTRATE PROCYSBI GRANULE, DELAYED RELEASE ORAL EQ 300MG BASE/PACKET 10905662 08/16/2036
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
RX 03/02/2021
N203389 CYSTEAMINE BITARTRATE PROCYSBI CAPSULE, DELAYED RELEASE ORAL EQ 25MG BASE 10905662*PED 02/16/2037
RX
N203389 CYSTEAMINE BITARTRATE PROCYSBI CAPSULE, DELAYED RELEASE ORAL EQ 75MG BASE 10905662*PED 02/16/2037
RX
N213491 CYSTEAMINE BITARTRATE PROCYSBI GRANULE, DELAYED RELEASE ORAL EQ 75MG BASE/PACKET 10905662*PED 02/16/2037
RX
N213491 CYSTEAMINE BITARTRATE PROCYSBI GRANULE, DELAYED RELEASE ORAL EQ 300MG BASE/PACKET 10905662*PED 02/16/2037
RX
N216264 INDIGOTINDISULFONATE SODIUM BLUDIGO SOLUTION INTRAVENOUS 40MG/5ML (8MG/ML) 10927258 12/23/2037 DS
RX 08/01/2022
N212295 REMIMAZOLAM BESYLATE BYFAVO POWDER INTRAVENOUS EQ 20MG BASE/VIAL 10961250 07/10/2027 DP
U-2968 USE OF REMIMAZOLAM FOR INDUCTION AND MAINTENANCE OF PROCEDURAL SEDATION IN ADULTS UNDERGOING PROCEDURES LASTING 30 MINUTES OR LESS
RX 07/08/2022
N216285 DROSPIRENONE DROSPIRENONE TABLET, CHEWABLE ORAL 3.5MG 10987364 06/28/2031 DP
RX 07/13/2022
N206406 TACROLIMUS ENVARSUS XR TABLET, EXTENDED RELEASE ORAL EQ 0.75MG BASE 11077096 08/30/2024 DP
RX 07/08/2022
N206406 TACROLIMUS ENVARSUS XR TABLET, EXTENDED RELEASE ORAL EQ 4MG BASE 11077096 08/30/2024 DP
RX 07/08/2022
N206406 TACROLIMUS ENVARSUS XR TABLET, EXTENDED RELEASE ORAL EQ 1MG BASE 11077096 08/30/2024 DP
RX 07/08/2022
N206192 COBIMETINIB FUMARATE COTELLIC TABLET ORAL EQ 20MG BASE 11087354 06/22/2034
U-1776 METHOD OF USING COBIMETINIB FOR THE TREATMENT OF MELANOMA
RX 09/08/2021
N206192 COBIMETINIB FUMARATE COTELLIC TABLET ORAL EQ 20MG BASE 11087354*PED 12/22/2034
RX
N216285 DROSPIRENONE DROSPIRENONE TABLET, CHEWABLE ORAL 3.5MG 11123299 06/28/2031 DP
RX 07/13/2022
N206192 COBIMETINIB FUMARATE COTELLIC TABLET ORAL EQ 20MG BASE 11254649 06/30/2036 DS DP
U-1776 METHOD OF USING COBIMETINIB FOR THE TREATMENT OF MELANOMA
RX 03/21/2022
N206192 COBIMETINIB FUMARATE COTELLIC TABLET ORAL EQ 20MG BASE 11254649*PED 12/30/2036
RX
N215515 VUTRISIRAN AMVUTTRA SOLUTION SUBCUTANEOUS 25MG/0.5ML (25MG/0.5ML) 11286486 07/28/2036 DS DP
U-3396 AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
RX 07/13/2022
N216285 DROSPIRENONE DROSPIRENONE TABLET, CHEWABLE ORAL 3.5MG 11291632 06/28/2031 DP
RX 07/13/2022
N216285 DROSPIRENONE DROSPIRENONE TABLET, CHEWABLE ORAL 3.5MG 11291633 06/28/2031 DP
RX 07/13/2022
N209195 SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR VOSEVI TABLET ORAL 400MG;100MG;100MG 11338007 06/01/2037 DP
U-2039 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1, 2, 3, 4, 5, OR 6 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING AN NS5A INHIBITOR
RX 06/17/2022
N209195 SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR VOSEVI TABLET ORAL 400MG;100MG;100MG 11338007 06/01/2037 DP
U-2040 TREATMENT OF ADULT PATIENTS WITH CHRONIC HCV INFECTION WHO HAVE GENOTYPE 1A OR 3 INFECTION AND HAVE PREVIOUSLY BEEN TREATED WITH AN HCV REGIMEN CONTAINING SOFOSBUVIR WITHOUT AN NS5A INHIBITOR
RX 06/17/2022
N209195 SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR VOSEVI TABLET ORAL 400MG;100MG;100MG 11338007*PED 12/01/2037
RX
N216285 DROSPIRENONE DROSPIRENONE TABLET, CHEWABLE ORAL 3.5MG 11351122 06/28/2031 DP
RX 07/13/2022
N213378 OLANZAPINE; SAMIDORPHAN L-MALATE LYBALVI TABLET ORAL 20MG;EQ 10MG BASE 11351166 08/23/2031
U-3141 METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN
RX 07/11/2022
N213378 OLANZAPINE; SAMIDORPHAN L-MALATE LYBALVI TABLET ORAL 20MG;EQ 10MG BASE 11351166 08/23/2031
U-3140 METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN
RX 07/11/2022
N213378 OLANZAPINE; SAMIDORPHAN L-MALATE LYBALVI TABLET ORAL 5MG;EQ 10MG BASE 11351166 08/23/2031
U-3141 METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN
RX 07/11/2022
N213378 OLANZAPINE; SAMIDORPHAN L-MALATE LYBALVI TABLET ORAL 5MG;EQ 10MG BASE 11351166 08/23/2031
U-3140 METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN
RX 07/11/2022
N213378 OLANZAPINE; SAMIDORPHAN L-MALATE LYBALVI TABLET ORAL 15MG;EQ 10MG BASE 11351166 08/23/2031
U-3141 METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN
RX 07/11/2022
N213378 OLANZAPINE; SAMIDORPHAN L-MALATE LYBALVI TABLET ORAL 15MG;EQ 10MG BASE 11351166 08/23/2031
U-3140 METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN
RX 07/11/2022
N213378 OLANZAPINE; SAMIDORPHAN L-MALATE LYBALVI TABLET ORAL 10MG;EQ 10MG BASE 11351166 08/23/2031
U-3141 METHOD OF TREATING BIPOLAR DISORDER BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN
RX 07/11/2022
N213378 OLANZAPINE; SAMIDORPHAN L-MALATE LYBALVI TABLET ORAL 10MG;EQ 10MG BASE 11351166 08/23/2031
U-3140 METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING THE ATYPICAL ANTIPSYCHOTIC OLANZAPINE AND SAMIDORPHAN
RX 07/11/2022
N210365 CANNABIDIOL EPIDIOLEX SOLUTION ORAL 100MG/ML 11357741 06/17/2035
U-2862 USE FOR THE TREATMENT OF FOCAL SEIZURES IN PATIENTS WITH DRAVET SYNDROME
RX 07/13/2022
N209510 AMISULPRIDE BARHEMSYS SOLUTION INTRAVENOUS 5MG/2ML (2.5MG/ML) 11357753 02/09/2038
U-2754 TREATMENT OF POST-OPERATIVE NAUSEA AND VOMITING
RX 07/08/2022
N209510 AMISULPRIDE BARHEMSYS SOLUTION INTRAVENOUS 10MG/4ML (2.5MG/ML) 11357753 02/09/2038
U-2754 TREATMENT OF POST-OPERATIVE NAUSEA AND VOMITING
RX 07/08/2022
N208623 MIGALASTAT HYDROCHLORIDE GALAFOLD CAPSULE ORAL EQ 123MG BASE 11357764 05/30/2038 DS
RX 06/28/2022
N208623 MIGALASTAT HYDROCHLORIDE GALAFOLD CAPSULE ORAL EQ 123MG BASE 11357765 05/30/2038 DS
RX 06/28/2022
N208798 FLUTICASONE PROPIONATE ARMONAIR DIGIHALER POWDER INHALATION 0.03MG/INH 11357935 09/24/2038 DP
DISCN 07/13/2022
N205636 ALBUTEROL SULFATE PROAIR DIGIHALER POWDER, METERED INHALATION EQ 0.09MG BASE/INH 11357935 09/24/2038 DP
RX 07/13/2022
N208799 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE AIRDUO DIGIHALER POWDER INHALATION 0.113MG/INH;EQ 0.014MG BASE/INH 11357935 09/24/2038 DP
RX 07/13/2022
N208799 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE AIRDUO DIGIHALER POWDER INHALATION 0.232MG/INH;EQ 0.014MG BASE/INH 11357935 09/24/2038 DP
RX 07/13/2022
N208799 FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE AIRDUO DIGIHALER POWDER INHALATION 0.055MG/INH;EQ 0.014MG BASE/INH 11357935 09/24/2038 DP
RX 07/13/2022
N208798 FLUTICASONE PROPIONATE ARMONAIR DIGIHALER POWDER INHALATION 0.232MG/INH 11357935 09/24/2038 DP
RX 07/13/2022
N208798 FLUTICASONE PROPIONATE ARMONAIR DIGIHALER POWDER INHALATION 0.113MG/INH 11357935 09/24/2038 DP
RX 07/13/2022
N208798 FLUTICASONE PROPIONATE ARMONAIR DIGIHALER POWDER INHALATION 0.055MG/INH 11357935 09/24/2038 DP
RX 07/13/2022
N208088 TESTOSTERONE UNDECANOATE TLANDO CAPSULE ORAL 112.5MG 11364249 11/30/2030
U-1500 TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED).
RX 07/19/2022
N215498 ODEVIXIBAT BYLVAY CAPSULE ORAL 0.4MG 11365182 06/20/2039
U-3187 METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
RX 07/12/2022
N215498 ODEVIXIBAT BYLVAY CAPSULE ORAL 0.4MG 11365182 06/20/2039
U-3186 METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
RX 07/12/2022
N215498 ODEVIXIBAT BYLVAY CAPSULE, PELLETS ORAL 0.2MG 11365182 06/20/2039
U-3187 METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
RX 07/12/2022
N215498 ODEVIXIBAT BYLVAY CAPSULE, PELLETS ORAL 0.2MG 11365182 06/20/2039
U-3186 METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
RX 07/12/2022
N215498 ODEVIXIBAT BYLVAY CAPSULE, PELLETS ORAL 0.6MG 11365182 06/20/2039
U-3187 METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
RX 07/12/2022
N215498 ODEVIXIBAT BYLVAY CAPSULE, PELLETS ORAL 0.6MG 11365182 06/20/2039
U-3186 METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
RX 07/12/2022
N215498 ODEVIXIBAT BYLVAY CAPSULE ORAL 1.2MG 11365182 06/20/2039
U-3187 METHOD OF REDUCING SERUM BILE ACIDS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
RX 07/12/2022
N215498 ODEVIXIBAT BYLVAY CAPSULE ORAL 1.2MG 11365182 06/20/2039
U-3186 METHOD OF TREATING PRURITUS IN PATIENTS 3 MONTHS OR OLDER SUFFERING FROM PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS (PFIC)
RX 07/12/2022
N211675 UPADACITINIB RINVOQ TABLET, EXTENDED RELEASE ORAL 15MG 11365198 10/17/2036
U-3275 TREATMENT OF ADULTS WITH ACTIVE PSORIATIC ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE OR INTOLERANCE TO ONE OR MORE TNF BLOCKERS
RX 07/20/2022
N207986 CIPROFLOXACIN OTIPRIO INJECTABLE, SUSPENSION OTIC 6% (60MG/ML) 11369566 04/21/2029 DP
RX 07/14/2022
N202057 ICOSAPENT ETHYL VASCEPA CAPSULE ORAL 1GM 11369582 06/28/2033
U-2841 USE OF VASCEPA WITH HIGH INTENSITY STATIN THERAPY TO REDUCE THE RISK OF A CV EVENT IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS AND (1) ESTABLISHED CV DISEASE, OR (2) DIABETES MELLITUS AND TWO OR MORE ADDITIONAL RISK FACTORS FOR CV DISEASE
RX 07/28/2022
N202057 ICOSAPENT ETHYL VASCEPA CAPSULE ORAL 500MG 11369582 06/28/2033
U-2841 USE OF VASCEPA WITH HIGH INTENSITY STATIN THERAPY TO REDUCE THE RISK OF A CV EVENT IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS AND (1) ESTABLISHED CV DISEASE, OR (2) DIABETES MELLITUS AND TWO OR MORE ADDITIONAL RISK FACTORS FOR CV DISEASE
RX 07/28/2022
N215841 GALLIUM GA-68 GOZETOTIDE LOCAMETZ POWDER INTRAVENOUS N/A 11369590 08/15/2028 DS DP
U-3400 FOR USE AFTER RADIOLABELING WITH GALLIUM-68, FOR POSITRON EMISSION TOMOGRAPHY OF PROSTATE-SPECIFIC MEMBRANE ANTIGEN (PSMA)-POSITIVE LESIONS IN MEN WITH PROSTATE CANCER
RX 07/28/2022
N207793 IRINOTECAN HYDROCHLORIDE ONIVYDE INJECTABLE, LIPOSOMAL INTRAVENOUS EQ 43MG BASE/10ML (EQ 4.3MG BASE/ML) 11369597 06/12/2033
U-1848 TREATMENT OF METASTATIC ADENOCARCINOMA OF THE PANCREAS THAT HAS PROGRESSED ON GEMCITABINE-BASED THERAPY, IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN
RX 07/20/2022
N208573 VENETOCLAX VENCLEXTA TABLET ORAL 50MG 11369599 05/23/2032 DP
RX 07/20/2022
N208573 VENETOCLAX VENCLEXTA TABLET ORAL 100MG 11369599 05/23/2032 DP
RX 07/20/2022
N208573 VENETOCLAX VENCLEXTA TABLET ORAL 10MG 11369599 05/23/2032 DP
RX 07/20/2022
N208623 MIGALASTAT HYDROCHLORIDE GALAFOLD CAPSULE ORAL EQ 123MG BASE 11376244 05/30/2038 DS
RX 07/25/2022
N214662 MARALIXIBAT CHLORIDE LIVMARLI SOLUTION ORAL EQ 9.5MG BASE/ML 11376251 10/26/2032
U-3290 TREATMENT OF CHOLESTATIC PRURITUS IN PATIENTS WITH ALAGILLE SYNDROME (ALGS)
RX 07/19/2022
N214522 TADALAFIL TADLIQ SUSPENSION ORAL 20MG/5ML 11382917 12/24/2038 DP
U-3397 TADLIQ IS INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO IMPROVE EXERCISE ABILITY
RX 07/13/2022
N214787 REMDESIVIR VEKLURY SOLUTION INTRAVENOUS 100MG/20ML (5MG/ML) 11382926 09/16/2036
U-3367 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN ADULTS AND PEDIATRIC PATIENTS (AT LEAST 28 DAYS OF AGE AND 3 KG) REQUIRING HOSPITALIZATION
RX 08/02/2022
N214787 REMDESIVIR VEKLURY SOLUTION INTRAVENOUS 100MG/20ML (5MG/ML) 11382926 09/16/2036
U-3368 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN NON-HOSPITALIZED ADULTS AND PEDIATRIC PATIENTS (AT LEAST 28 DAYS OF AGE AND 3 KG)
RX 08/02/2022
N214787 REMDESIVIR VEKLURY POWDER INTRAVENOUS 100MG/VIAL 11382926 09/16/2036
U-3367 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN ADULTS AND PEDIATRIC PATIENTS (AT LEAST 28 DAYS OF AGE AND 3 KG) REQUIRING HOSPITALIZATION
RX 08/02/2022
N214787 REMDESIVIR VEKLURY POWDER INTRAVENOUS 100MG/VIAL 11382926 09/16/2036
U-3368 TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN NON-HOSPITALIZED ADULTS AND PEDIATRIC PATIENTS (AT LEAST 28 DAYS OF AGE AND 3 KG)
RX 08/02/2022
N213051 SEMAGLUTIDE RYBELSUS TABLET ORAL 7MG 11382957 12/16/2031 DP
RX 07/26/2022
N213051 SEMAGLUTIDE RYBELSUS TABLET ORAL 14MG 11382957 12/16/2031 DP
RX 07/26/2022
N213051 SEMAGLUTIDE RYBELSUS TABLET ORAL 3MG 11382957 12/16/2031 DP
RX 07/26/2022
N208623 MIGALASTAT HYDROCHLORIDE GALAFOLD CAPSULE ORAL EQ 123MG BASE 11389436 05/30/2038
U-2371 THE TREATMENT OF FABRY PATIENTS
RX 07/25/2022
N208623 MIGALASTAT HYDROCHLORIDE GALAFOLD CAPSULE ORAL EQ 123MG BASE 11389437 05/30/2038
U-2371 THE TREATMENT OF FABRY PATIENTS
RX 07/25/2022
N209478 SPIRONOLACTONE CAROSPIR SUSPENSION ORAL 25MG/5ML 11389461 10/28/2036 DP
RX 07/22/2022
N209478 SPIRONOLACTONE CAROSPIR SUSPENSION ORAL 25MG/5ML 11395828 10/28/2036
U-3401 CAROSPIR IS INDICATED AS AN ADD-ON THERAPY FOR THE TREATMENT OF HYPERTENSION, TO LOWER BLOOD PRESSURE IN ADULT PATIENTS WHO ARE NOT ADEQUATELY CONTROLLED ON OTHER AGENTS
RX 08/02/2022
N209478 SPIRONOLACTONE CAROSPIR SUSPENSION ORAL 25MG/5ML 11395828 10/28/2036
U-3402 CAROSPIR IS INDICATED FOR THE MANAGEMENT OF EDEMA IN ADULT CIRRHOTIC PATIENTS WHEN EDEMA IS NOT RESPONSIVE TO FLUID AND SODIUM RESTRICTION
RX 08/02/2022
N209478 SPIRONOLACTONE CAROSPIR SUSPENSION ORAL 25MG/5ML 11395828 10/28/2036
U-2109 CAROSPIR IS INDICATED FOR TREATMENT OF NYHA CLASS III-IV HEART FAILURE AND REDUCED EJECTION FRACTION TO INCREASE SURVIVAL, MANAGE EDEMA, AND TO REDUCE THE NEED FOR HOSPITALIZATION FOR HEART FAILURE
RX 08/02/2022
N215429 VENLAFAXINE BESYLATE VENLAFAXINE BESYLATE TABLET, EXTENDED RELEASE ORAL EQ 112.5MG BASE 6717015 03/27/2023 DS DP
U-451 TREATMENT OF DEPRESSION AND GENERALIZED ANXIETY DISORDER
RX 07/20/2022
N208794 TELOTRISTAT ETIPRATE XERMELO TABLET ORAL EQ 250MG BASE 7709493 02/28/2031 DS
U-1979 THE TREATMENT OF CARCINOID SYNDROME DIARRHEA IN COMBINATION WITH SOMATOSTATIN ANALOG (SSA) THERAPY IN ADULTS INADEQUATELY CONTROLLED BY SSA THERAPY
RX 03/23/2017
N215429 VENLAFAXINE BESYLATE VENLAFAXINE BESYLATE TABLET, EXTENDED RELEASE ORAL EQ 112.5MG BASE 7776358 05/16/2028 DP
RX 07/20/2022
N206192 COBIMETINIB FUMARATE COTELLIC TABLET ORAL EQ 20MG BASE 7803839 11/10/2029 DS DP
RX 12/09/2015
N206192 COBIMETINIB FUMARATE COTELLIC TABLET ORAL EQ 20MG BASE 7803839*PED 05/10/2030
RX
N215904 GANAXOLONE ZTALMY SUSPENSION ORAL 50MG/ML 7858609 11/28/2026 DP
RX 06/02/2022
N209884 SIPONIMOD FUMARIC ACID MAYZENT TABLET ORAL EQ 0.25MG BASE 7939519 08/27/2028 DS DP
RX 04/19/2019
N209884 SIPONIMOD FUMARIC ACID MAYZENT TABLET ORAL EQ 2MG BASE 7939519 08/27/2028 DS DP
RX 04/19/2019
N209884 SIPONIMOD FUMARIC ACID MAYZENT TABLET ORAL EQ 1MG BASE 7939519 08/27/2028 DS DP
RX 09/22/2021
N215152 AMOXICILLIN; CLARITHROMYCIN; VONOPRAZAN FUMARATE VOQUEZNA TRIPLE PAK CAPSULE, TABLET, TABLET ORAL 500MG;500MG;EQ 20MG BASE 7977488 08/11/2028 DS
RX 07/27/2022
N215153 AMOXICILLIN; VONOPRAZAN FUMARATE VOQUEZNA DUAL PAK CAPSULE, TABLET ORAL 500MG;EQ 20MG BASE 7977488 08/11/2028 DS
RX 07/27/2022
N215904 GANAXOLONE ZTALMY SUSPENSION ORAL 50MG/ML 8022054 11/28/2026 DP
RX 06/02/2022
N215515 VUTRISIRAN AMVUTTRA SOLUTION SUBCUTANEOUS 25MG/0.5ML (25MG/0.5ML) 8106022 12/12/2029 DS DP
U-3396 AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
RX 07/13/2022
N206192 COBIMETINIB FUMARATE COTELLIC TABLET ORAL EQ 20MG BASE 8362002 10/05/2026
U-1776 METHOD OF USING COBIMETINIB FOR THE TREATMENT OF MELANOMA
RX 12/09/2015
N206192 COBIMETINIB FUMARATE COTELLIC TABLET ORAL EQ 20MG BASE 8362002*PED 04/05/2027
RX
N022580 PHENTERMINE HYDROCHLORIDE; TOPIRAMATE QSYMIA CAPSULE, EXTENDED RELEASE ORAL EQ 3.75MG BASE;23MG 8580299 06/14/2029
U-3399 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2, AND PATIENTS AGE 12-17 WITH BMI >=30 KG/M2 AND IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX), EACH HAVING A WEIGHT-RELATED COMORBIDITY
RX 11/14/2013
N022580 PHENTERMINE HYDROCHLORIDE; TOPIRAMATE QSYMIA CAPSULE, EXTENDED RELEASE ORAL EQ 7.5MG BASE;46MG 8580299 06/14/2029
U-3399 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2, AND PATIENTS AGE 12-17 WITH BMI >=30 KG/M2 AND IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX), EACH HAVING A WEIGHT-RELATED COMORBIDITY
RX
N022580 PHENTERMINE HYDROCHLORIDE; TOPIRAMATE QSYMIA CAPSULE, EXTENDED RELEASE ORAL EQ 11.25MG BASE;69MG 8580299 06/14/2029
U-3399 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2, AND PATIENTS AGE 12-17 WITH BMI >=30 KG/M2 AND IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX), EACH HAVING A WEIGHT-RELATED COMORBIDITY
RX
N022580 PHENTERMINE HYDROCHLORIDE; TOPIRAMATE QSYMIA CAPSULE, EXTENDED RELEASE ORAL EQ 15MG BASE;92MG 8580299 06/14/2029
U-3399 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2, AND PATIENTS AGE 12-17 WITH BMI >=30 KG/M2 AND IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX), EACH HAVING A WEIGHT-RELATED COMORBIDITY
RX
N215515 VUTRISIRAN AMVUTTRA SOLUTION SUBCUTANEOUS 25MG/0.5ML (25MG/0.5ML) 8828956 12/04/2028 DS DP
U-3396 AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
RX 07/13/2022
N022580 PHENTERMINE HYDROCHLORIDE; TOPIRAMATE QSYMIA CAPSULE, EXTENDED RELEASE ORAL EQ 3.75MG BASE;23MG 8895057 06/09/2028
U-3398 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
RX 12/18/2014
N022580 PHENTERMINE HYDROCHLORIDE; TOPIRAMATE QSYMIA CAPSULE, EXTENDED RELEASE ORAL EQ 7.5MG BASE;46MG 8895057 06/09/2028
U-3398 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
RX 12/18/2014
N022580 PHENTERMINE HYDROCHLORIDE; TOPIRAMATE QSYMIA CAPSULE, EXTENDED RELEASE ORAL EQ 11.25MG BASE;69MG 8895057 06/09/2028
U-3398 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
RX 12/18/2014
N022580 PHENTERMINE HYDROCHLORIDE; TOPIRAMATE QSYMIA CAPSULE, EXTENDED RELEASE ORAL EQ 15MG BASE;92MG 8895057 06/09/2028
U-3398 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
RX 12/18/2014
N022580 PHENTERMINE HYDROCHLORIDE; TOPIRAMATE QSYMIA CAPSULE, EXTENDED RELEASE ORAL EQ 3.75MG BASE;23MG 9011906 06/09/2028
U-3398 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
RX 05/13/2015
N022580 PHENTERMINE HYDROCHLORIDE; TOPIRAMATE QSYMIA CAPSULE, EXTENDED RELEASE ORAL EQ 7.5MG BASE;46MG 9011906 06/09/2028
U-3398 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
RX 05/13/2015
N022580 PHENTERMINE HYDROCHLORIDE; TOPIRAMATE QSYMIA CAPSULE, EXTENDED RELEASE ORAL EQ 11.25MG BASE;69MG 9011906 06/09/2028
U-3398 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
RX 05/13/2015
N022580 PHENTERMINE HYDROCHLORIDE; TOPIRAMATE QSYMIA CAPSULE, EXTENDED RELEASE ORAL EQ 15MG BASE;92MG 9011906 06/09/2028
U-3398 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
RX 05/13/2015
N215152 AMOXICILLIN; CLARITHROMYCIN; VONOPRAZAN FUMARATE VOQUEZNA TRIPLE PAK CAPSULE, TABLET, TABLET ORAL 500MG;500MG;EQ 20MG BASE 9186411 08/11/2030 DP
RX 07/27/2022
N215153 AMOXICILLIN; VONOPRAZAN FUMARATE VOQUEZNA DUAL PAK CAPSULE, TABLET ORAL 500MG;EQ 20MG BASE 9186411 08/11/2030 DP
RX 07/27/2022
N215515 VUTRISIRAN AMVUTTRA SOLUTION SUBCUTANEOUS 25MG/0.5ML (25MG/0.5ML) 9370581 12/04/2028 DS DP
U-3396 AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
RX 07/13/2022
N215515 VUTRISIRAN AMVUTTRA SOLUTION SUBCUTANEOUS 25MG/0.5ML (25MG/0.5ML) 9399775 11/16/2032 DS DP
U-3396 AMVUTTRA IS INDICATED FOR THE TREATMENT OF THE POLYNEUROPATHY OF HEREDITARY TRANSTHYRETIN-MEDIATED AMYLOIDOSIS IN ADULTS
RX 07/13/2022
N202207 TECHNETIUM TC-99M TILMANOCEPT LYMPHOSEEK KIT INJECTABLE INJECTION N/A 9439985 01/30/2029 DP
RX 10/14/2016
N216285 DROSPIRENONE DROSPIRENONE TABLET, CHEWABLE ORAL 3.5MG 9603860 06/28/2031
U-2553 PREVENTION OF PREGNANCY IN FEMALES OF REPRODUCTIVE AGE
RX 07/13/2022
N213491 CYSTEAMINE BITARTRATE PROCYSBI GRANULE, DELAYED RELEASE ORAL EQ 75MG BASE/PACKET 9925156 01/26/2027 DP
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
RX 03/13/2020
N213491 CYSTEAMINE BITARTRATE PROCYSBI GRANULE, DELAYED RELEASE ORAL EQ 300MG BASE/PACKET 9925156 01/26/2027 DP
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
RX 03/13/2020
N203389 CYSTEAMINE BITARTRATE PROCYSBI CAPSULE, DELAYED RELEASE ORAL EQ 25MG BASE 9925156 01/26/2027 DS DP
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
RX 04/19/2018
N203389 CYSTEAMINE BITARTRATE PROCYSBI CAPSULE, DELAYED RELEASE ORAL EQ 75MG BASE 9925156 01/26/2027 DS DP
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
RX 04/19/2018
N203389 CYSTEAMINE BITARTRATE PROCYSBI CAPSULE, DELAYED RELEASE ORAL EQ 25MG BASE 9925156*PED 07/26/2027
RX
N203389 CYSTEAMINE BITARTRATE PROCYSBI CAPSULE, DELAYED RELEASE ORAL EQ 75MG BASE 9925156*PED 07/26/2027
RX
N213491 CYSTEAMINE BITARTRATE PROCYSBI GRANULE, DELAYED RELEASE ORAL EQ 75MG BASE/PACKET 9925156*PED 07/26/2027
RX
N213491 CYSTEAMINE BITARTRATE PROCYSBI GRANULE, DELAYED RELEASE ORAL EQ 300MG BASE/PACKET 9925156*PED 07/26/2027
RX
N213491 CYSTEAMINE BITARTRATE PROCYSBI GRANULE, DELAYED RELEASE ORAL EQ 75MG BASE/PACKET 9925157 01/26/2027 DP
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
RX 03/13/2020
N213491 CYSTEAMINE BITARTRATE PROCYSBI GRANULE, DELAYED RELEASE ORAL EQ 300MG BASE/PACKET 9925157 01/26/2027 DP
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
RX 03/13/2020
N203389 CYSTEAMINE BITARTRATE PROCYSBI CAPSULE, DELAYED RELEASE ORAL EQ 25MG BASE 9925157 01/26/2027 DS DP
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
RX 04/19/2018
N203389 CYSTEAMINE BITARTRATE PROCYSBI CAPSULE, DELAYED RELEASE ORAL EQ 75MG BASE 9925157 01/26/2027 DS DP
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
RX 04/19/2018
N203389 CYSTEAMINE BITARTRATE PROCYSBI CAPSULE, DELAYED RELEASE ORAL EQ 25MG BASE 9925157*PED 07/26/2027
RX
N203389 CYSTEAMINE BITARTRATE PROCYSBI CAPSULE, DELAYED RELEASE ORAL EQ 75MG BASE 9925157*PED 07/26/2027
RX
N213491 CYSTEAMINE BITARTRATE PROCYSBI GRANULE, DELAYED RELEASE ORAL EQ 75MG BASE/PACKET 9925157*PED 07/26/2027
RX
N213491 CYSTEAMINE BITARTRATE PROCYSBI GRANULE, DELAYED RELEASE ORAL EQ 300MG BASE/PACKET 9925157*PED 07/26/2027
RX
N213491 CYSTEAMINE BITARTRATE PROCYSBI GRANULE, DELAYED RELEASE ORAL EQ 75MG BASE/PACKET 9925158 01/26/2027 DP
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
RX 03/13/2020
N213491 CYSTEAMINE BITARTRATE PROCYSBI GRANULE, DELAYED RELEASE ORAL EQ 300MG BASE/PACKET 9925158 01/26/2027 DP
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
RX 03/13/2020
N203389 CYSTEAMINE BITARTRATE PROCYSBI CAPSULE, DELAYED RELEASE ORAL EQ 25MG BASE 9925158 01/26/2027 DS DP
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
RX 04/19/2018
N203389 CYSTEAMINE BITARTRATE PROCYSBI CAPSULE, DELAYED RELEASE ORAL EQ 75MG BASE 9925158 01/26/2027 DS DP
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO DIVIDED DOSES
RX 04/19/2018
N203389 CYSTEAMINE BITARTRATE PROCYSBI CAPSULE, DELAYED RELEASE ORAL EQ 25MG BASE 9925158*PED 07/26/2027
RX
N203389 CYSTEAMINE BITARTRATE PROCYSBI CAPSULE, DELAYED RELEASE ORAL EQ 75MG BASE 9925158*PED 07/26/2027
RX
N213491 CYSTEAMINE BITARTRATE PROCYSBI GRANULE, DELAYED RELEASE ORAL EQ 75MG BASE/PACKET 9925158*PED 07/26/2027
RX
N213491 CYSTEAMINE BITARTRATE PROCYSBI GRANULE, DELAYED RELEASE ORAL EQ 300MG BASE/PACKET 9925158*PED 07/26/2027
RX
N204370 CARIPRAZINE HYDROCHLORIDE VRAYLAR CAPSULE ORAL EQ 6MG BASE RE49110 07/16/2029
U-2544 TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
RX 07/21/2022
N204370 CARIPRAZINE HYDROCHLORIDE VRAYLAR CAPSULE ORAL EQ 6MG BASE RE49110 07/16/2029
U-2545 TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE
RX 07/21/2022
N204370 CARIPRAZINE HYDROCHLORIDE VRAYLAR CAPSULE ORAL EQ 6MG BASE RE49110 07/16/2029
U-2543 TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE
RX 07/21/2022
N204370 CARIPRAZINE HYDROCHLORIDE VRAYLAR CAPSULE ORAL EQ 4.5MG BASE RE49110 07/16/2029
U-2544 TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
RX 07/21/2022
N204370 CARIPRAZINE HYDROCHLORIDE VRAYLAR CAPSULE ORAL EQ 4.5MG BASE RE49110 07/16/2029
U-2545 TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE
RX 07/21/2022
N204370 CARIPRAZINE HYDROCHLORIDE VRAYLAR CAPSULE ORAL EQ 4.5MG BASE RE49110 07/16/2029
U-2543 TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE
RX 07/21/2022
N204370 CARIPRAZINE HYDROCHLORIDE VRAYLAR CAPSULE ORAL EQ 3MG BASE RE49110 07/16/2029
U-2544 TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
RX 07/21/2022
N204370 CARIPRAZINE HYDROCHLORIDE VRAYLAR CAPSULE ORAL EQ 3MG BASE RE49110 07/16/2029
U-2545 TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE
RX 07/21/2022
N204370 CARIPRAZINE HYDROCHLORIDE VRAYLAR CAPSULE ORAL EQ 3MG BASE RE49110 07/16/2029
U-2543 TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE
RX 07/21/2022
N204370 CARIPRAZINE HYDROCHLORIDE VRAYLAR CAPSULE ORAL EQ 1.5MG BASE RE49110 07/16/2029
U-2544 TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
RX 07/21/2022
N204370 CARIPRAZINE HYDROCHLORIDE VRAYLAR CAPSULE ORAL EQ 1.5MG BASE RE49110 07/16/2029
U-2545 TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE
RX 07/21/2022
N204370 CARIPRAZINE HYDROCHLORIDE VRAYLAR CAPSULE ORAL EQ 1.5MG BASE RE49110 07/16/2029
U-2543 TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE
RX 07/21/2022

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