testosterone undecanoate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
androgens/anabolic steroids 2608 5949-44-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • testosterone undecanoate
  • testosterone undecylate
  • Molecular weight: 456.71
  • Formula: C30H48O3
  • CLOGP: 9.12
  • LIPINSKI: 1
  • HAC: 3
  • HDO: 0
  • TPSA: 43.37
  • ALOGS: -6.79
  • ROTB: 11
  • Status: ONP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
BA (Bioavailability) 4 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 5.206 High 0.80
caco2-efflux Caco-2 efflux ratio (BA/AB) 1.035 High 0.80
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 0.269 10^-6 cm/s High 0.80
dh-clint Dog hepatocyte intrinsic clearance 83.368 uL/min/10^6 cells High 0.80
dppb Dog plasma protein binding (% unbound) 0.110 % High 0.80
fcs-ppb Fetal calf serum protein binding (% unbound) 0.060 % High 0.80
herg hERG pIC50 4.886 pIC50 High 0.80
hh-clint Human hepatocyte intrinsic clearance 81.470 uL/min/10^6 cells High 0.80
hlm-clint Human liver microsomal intrinsic clearance 111.944 uL/min/mg protein High 0.80
hppb Human plasma protein binding (% unbound) 0.270 % High 0.80
kinase-safety-class ACVR2A,ACVR2B,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,GRK2,IKBKB,ITK,JAK2,MAP2K6,MAP3K7,MAPK10,MAPK7,MAPKAPK2,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIK3CG,PIM2,PRKDC,SIK2,STK33,SYK,TEK,TGFBR1,TTK,ZAP70 41
kinase-selectivity-class AXL,EIF2AK3,GRK2,MAP2K6 4
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 0.044 High 0.80
mh-clint Mouse hepatocyte intrinsic clearance 168.267 High 0.80
mppb Mouse plasma protein binding (% unbound) 0.150 High 0.80
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 0.034 High 0.80
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 0.180 % High 0.80
rh-clint Rat hepatocyte intrinsic clearance 137.088 uL/min/10^6 cells High 0.80
rh-fuinc Rat hepatocyte fraction unbound in incubation 0.150 % High 0.80
rppb Rat plasma protein binding (% unbound) 0.140 % High 0.80
solubility-dd Solubility at pH 7.4 in DMSO 0.745 uM High 0.80

Approvals:

DateAgencyCompanyOrphan
March 5, 2014 FDA ENDO PHARMS INC

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Pulmonary oil microembolism 346.71 28.15 40 1749 21 42619525
Cough 97.44 28.15 71 1718 178032 42441514
Blood testosterone decreased 90.58 28.15 24 1765 4878 42614668
Polycythaemia 67.25 28.15 17 1772 2869 42616677
Pulmonary microemboli 63.22 28.15 8 1781 18 42619528
Microembolism 61.81 28.15 8 1781 23 42619523
Drug ineffective 60.99 28.15 100 1689 630097 41989449
Haematocrit increased 54.30 28.15 14 1775 2553 42616993
Blood testosterone increased 50.58 28.15 12 1777 1555 42617991
Inappropriate schedule of product administration 40.69 28.15 33 1756 95869 42523677
Pneumonia haemophilus 33.57 28.15 8 1781 1056 42618490

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Pulmonary oil microembolism 279.47 27.10 29 1412 25 110587833
Cough 71.34 27.10 54 1387 461587 110126271
Blood testosterone decreased 57.43 27.10 12 1429 2836 110585022
Polycythaemia 55.76 27.10 12 1429 3263 110584595
Pulmonary microemboli 51.10 27.10 6 1435 28 110587830
Blood testosterone increased 46.85 27.10 9 1432 1393 110586465
Pneumonia haemophilus 35.43 27.10 8 1433 2707 110585151
Idiopathic intracranial hypertension 32.44 27.10 8 1433 3944 110583914
Microembolism 31.06 27.10 4 1437 44 110587814
Haematocrit increased 30.64 27.10 8 1433 4951 110582907
Inappropriate schedule of product administration 27.32 27.10 22 1419 203615 110384243

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
FDA CS M0001109 Androstanes
FDA MoA N0000000146 Androgen Receptor Agonists
MeSH PA D000728 Androgens
MeSH PA D006728 Hormones
FDA EPC N0000175824 Androgen
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35620 vasodilator agent
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:50113 androgen
CHEBI has role CHEBI:50779 appetite enhancer
CHEBI has role CHEBI:50864 insulin-sensitizing drug
CHEBI has role CHEBI:74518 anti-obesity agent
CHEBI has role CHEBI:75771 mouse metabolite
CHEBI has role CHEBI:77746 human metabolite
CHEBI has role CHEBI:83056 <em>Daphnia magna</em> metabolite
CHEBI has role CHEBI:176497 geroprotector
CHEBI has role CHEBI:231911 renoprotective agent

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Hypogonadotropic hypogonadism indication 33927004
Deficiency or absence of endogenous testosterone indication 38825009
Primary hypogonadism indication 370999003




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
158MG JATENZO TOLMAR N206089 March 27, 2019 RX CAPSULE ORAL 11331325 Jan. 6, 2027 METHOD OF TREATING TESTOSTERONE DEFICIENCY
198MG JATENZO TOLMAR N206089 March 27, 2019 RX CAPSULE ORAL 11331325 Jan. 6, 2027 METHOD OF TREATING TESTOSTERONE DEFICIENCY
237MG JATENZO TOLMAR N206089 March 27, 2019 RX CAPSULE ORAL 11331325 Jan. 6, 2027 METHOD OF TREATING TESTOSTERONE DEFICIENCY
750MG/3ML (250MG/ML) AVEED ENDO OPERATIONS N022219 March 5, 2014 RX INJECTABLE INTRAMUSCULAR 8338395 May 8, 2027 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).
112.5MG TLANDO VERITY N208088 March 28, 2022 RX CAPSULE ORAL 11304960 Jan. 8, 2029 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).
112.5MG TLANDO VERITY N208088 March 28, 2022 RX CAPSULE ORAL 8778922 Jan. 8, 2029 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).
112.5MG TLANDO VERITY N208088 March 28, 2022 RX CAPSULE ORAL 8865695 Jan. 8, 2029 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).
158MG JATENZO TOLMAR N206089 March 27, 2019 RX CAPSULE ORAL 8241664 March 29, 2029 METHOD OF TREATING TESTOSTERONE DEFICIENCY
198MG JATENZO TOLMAR N206089 March 27, 2019 RX CAPSULE ORAL 8241664 March 29, 2029 METHOD OF TREATING TESTOSTERONE DEFICIENCY
237MG JATENZO TOLMAR N206089 March 27, 2019 RX CAPSULE ORAL 8241664 March 29, 2029 METHOD OF TREATING TESTOSTERONE DEFICIENCY
158MG JATENZO TOLMAR N206089 March 27, 2019 RX CAPSULE ORAL 10543219 April 12, 2030 METHOD OF TREATING TESTOSTERONE DEFICIENCY
158MG JATENZO TOLMAR N206089 March 27, 2019 RX CAPSULE ORAL 11179403 April 12, 2030 METHOD OF TREATING TESTOSTERONE DEFICIENCY
158MG JATENZO TOLMAR N206089 March 27, 2019 RX CAPSULE ORAL 11426416 April 12, 2030 A METHOD OF TREATING TESTOSTERONE DEFICIENCY IN MEN
198MG JATENZO TOLMAR N206089 March 27, 2019 RX CAPSULE ORAL 10543219 April 12, 2030 METHOD OF TREATING TESTOSTERONE DEFICIENCY
198MG JATENZO TOLMAR N206089 March 27, 2019 RX CAPSULE ORAL 11179403 April 12, 2030 METHOD OF TREATING TESTOSTERONE DEFICIENCY
198MG JATENZO TOLMAR N206089 March 27, 2019 RX CAPSULE ORAL 11426416 April 12, 2030 A METHOD OF TREATING TESTOSTERONE DEFICIENCY IN MEN
237MG JATENZO TOLMAR N206089 March 27, 2019 RX CAPSULE ORAL 10543219 April 12, 2030 METHOD OF TREATING TESTOSTERONE DEFICIENCY
237MG JATENZO TOLMAR N206089 March 27, 2019 RX CAPSULE ORAL 11179403 April 12, 2030 METHOD OF TREATING TESTOSTERONE DEFICIENCY
237MG JATENZO TOLMAR N206089 March 27, 2019 RX CAPSULE ORAL 11426416 April 12, 2030 A METHOD OF TREATING TESTOSTERONE DEFICIENCY IN MEN
112.5MG TLANDO VERITY N208088 March 28, 2022 RX CAPSULE ORAL 10226473 Nov. 30, 2030 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).
112.5MG TLANDO VERITY N208088 March 28, 2022 RX CAPSULE ORAL 10716794 Nov. 30, 2030 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).
112.5MG TLANDO VERITY N208088 March 28, 2022 RX CAPSULE ORAL 11311555 Nov. 30, 2030 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).
112.5MG TLANDO VERITY N208088 March 28, 2022 RX CAPSULE ORAL 11364249 Nov. 30, 2030 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).
112.5MG TLANDO VERITY N208088 March 28, 2022 RX CAPSULE ORAL 11433083 Nov. 30, 2030 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).
112.5MG TLANDO VERITY N208088 March 28, 2022 RX CAPSULE ORAL 9943527 Nov. 30, 2030 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).
112.5MG TLANDO VERITY N208088 March 28, 2022 RX CAPSULE ORAL 9949985 Nov. 30, 2030 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).
158MG JATENZO TOLMAR N206089 March 27, 2019 RX CAPSULE ORAL 8492369 Dec. 20, 2030 METHOD OF TREATING TESTOSTERONE DEFICIENCY
198MG JATENZO TOLMAR N206089 March 27, 2019 RX CAPSULE ORAL 8492369 Dec. 20, 2030 METHOD OF TREATING TESTOSTERONE DEFICIENCY
237MG JATENZO TOLMAR N206089 March 27, 2019 RX CAPSULE ORAL 8492369 Dec. 20, 2030 METHOD OF TREATING TESTOSTERONE DEFICIENCY
100MG KYZATREX MARIUS N213953 July 27, 2022 DISCN CAPSULE ORAL 10576089 Dec. 31, 2030 METHOD OF TREATING TESTOSTERONE DEFICIENCY
150MG KYZATREX MARIUS N213953 July 27, 2022 RX CAPSULE ORAL 10576089 Dec. 31, 2030 METHOD OF TREATING TESTOSTERONE DEFICIENCY
200MG KYZATREX MARIUS N213953 July 27, 2022 RX CAPSULE ORAL 10576089 Dec. 31, 2030 METHOD OF TREATING TESTOSTERONE DEFICIENCY
100MG KYZATREX MARIUS N213953 July 27, 2022 DISCN CAPSULE ORAL 11617758 March 15, 2033 METHOD OF TREATING TESTOSTERONE DEFICIENCY
100MG KYZATREX MARIUS N213953 July 27, 2022 DISCN CAPSULE ORAL 12357643 March 15, 2033 METHOD OF TREATING TESTOSTERONE DEFICIENCY
150MG KYZATREX MARIUS N213953 July 27, 2022 RX CAPSULE ORAL 11617758 March 15, 2033 METHOD OF TREATING TESTOSTERONE DEFICIENCY
150MG KYZATREX MARIUS N213953 July 27, 2022 RX CAPSULE ORAL 12357643 March 15, 2033 METHOD OF TREATING TESTOSTERONE DEFICIENCY
200MG KYZATREX MARIUS N213953 July 27, 2022 RX CAPSULE ORAL 11617758 March 15, 2033 METHOD OF TREATING TESTOSTERONE DEFICIENCY
200MG KYZATREX MARIUS N213953 July 27, 2022 RX CAPSULE ORAL 12357643 March 15, 2033 METHOD OF TREATING TESTOSTERONE DEFICIENCY
112.5MG TLANDO VERITY N208088 March 28, 2022 RX CAPSULE ORAL 11559530 Nov. 28, 2037 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).
112.5MG TLANDO VERITY N208088 March 28, 2022 RX CAPSULE ORAL 12310978 Feb. 21, 2039 METHODS OF RESTORING TESTOSTERONE CONCENTRATION FOR CONDITIONS ASSOCIATED WITH DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE IN A MALE SUBJECT
158MG JATENZO TOLMAR N206089 March 27, 2019 RX CAPSULE ORAL 11564933 April 12, 2039 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
158MG JATENZO TOLMAR N206089 March 27, 2019 RX CAPSULE ORAL 12605391 April 12, 2039 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
198MG JATENZO TOLMAR N206089 March 27, 2019 RX CAPSULE ORAL 11564933 April 12, 2039 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
198MG JATENZO TOLMAR N206089 March 27, 2019 RX CAPSULE ORAL 12605391 April 12, 2039 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
237MG JATENZO TOLMAR N206089 March 27, 2019 RX CAPSULE ORAL 11564933 April 12, 2039 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
237MG JATENZO TOLMAR N206089 March 27, 2019 RX CAPSULE ORAL 12605391 April 12, 2039 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
112.5MG TLANDO VERITY N208088 March 28, 2022 RX CAPSULE ORAL 12011503 Oct. 16, 2040 METHODS OF ADMINISTERING TESTOSTERONE UNDECANOATE FOR RESTORING TESTOSTERONE CONCENTRATION IN A HYPOGONADAL MALE SUBJECT
112.5MG TLANDO VERITY N208088 March 28, 2022 RX CAPSULE ORAL 12011503 Oct. 16, 2040 METHODS OF CONTINUING OR DISCONTINUING A DOSAGE REGIMEN OF A TESTOSTERONE UNDECANOATE PHARMACEUTICAL COMPOSITION TO A HYPOGONADAL MALE SUBJECT
100MG KYZATREX MARIUS N213953 July 27, 2022 DISCN CAPSULE ORAL 12403146 March 29, 2041 METHOD OF TREATING TESTOSTERONE DEFICIENCY
150MG KYZATREX MARIUS N213953 July 27, 2022 RX CAPSULE ORAL 12403146 March 29, 2041 METHOD OF TREATING TESTOSTERONE DEFICIENCY
200MG KYZATREX MARIUS N213953 July 27, 2022 RX CAPSULE ORAL 12403146 March 29, 2041 METHOD OF TREATING TESTOSTERONE DEFICIENCY
112.5MG TLANDO VERITY N208088 March 28, 2022 RX CAPSULE ORAL 11464735 April 28, 2041 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).

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Androgen receptor Nuclear hormone receptor AGONIST CHEMBL CHEMBL

External reference:

IDSource
4033172 VUID
N0000190487 NUI
D06087 KEGG_DRUG
4017484 VANDF
4033172 VANDF
C0076195 UMLSCUI
CHEBI:135741 CHEBI
TES PDB_CHEM_ID
CHEMBL2107067 ChEMBL_ID
DB13946 DRUGBANK_ID
C010792 MESH_SUPPLEMENTAL_RECORD_UI
H16A5VCT9C UNII
65157 PUBCHEM_CID
DB00624 DRUGBANK_ID
10379 RXNORM
15462 MMSL
2966 MMSL
5552 MMSL
d00558 MMSL
001245 NDDF
004105 NDDF
109033004 SNOMEDCT_US
395900004 SNOMEDCT_US
43688007 SNOMEDCT_US
C0039601 UMLSCUI
6013 PUBCHEM_CID
1900 INN_ID
D013739 MESH_DESCRIPTOR_UI
CHEBI:17347 CHEBI
H16A5VCT9C INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Aveed HUMAN PRESCRIPTION DRUG LABEL 1 67979-511 INJECTION 250 mg INTRAMUSCULAR NDA 29 sections
Jatenzo HUMAN PRESCRIPTION DRUG LABEL 1 69087-158 CAPSULE, LIQUID FILLED 158 mg ORAL NDA 32 sections
Jatenzo HUMAN PRESCRIPTION DRUG LABEL 1 69087-198 CAPSULE, LIQUID FILLED 198 mg ORAL NDA 32 sections
Jatenzo HUMAN PRESCRIPTION DRUG LABEL 1 69087-237 CAPSULE, LIQUID FILLED 237 mg ORAL NDA 32 sections
Undecatrex HUMAN PRESCRIPTION DRUG LABEL 1 73352-105 CAPSULE 200 mg ORAL NDA AUTHORIZED GENERIC 36 sections
Tlando HUMAN PRESCRIPTION DRUG LABEL 1 74676-0112 CAPSULE, LIQUID FILLED 112.50 mg ORAL NDA 33 sections
Kyzatrex HUMAN PRESCRIPTION DRUG LABEL 1 80603-101 CAPSULE, LIQUID FILLED 100 mg ORAL NDA 36 sections
Kyzatrex HUMAN PRESCRIPTION DRUG LABEL 1 80603-101 CAPSULE, LIQUID FILLED 100 mg ORAL NDA 36 sections
Kyzatrex HUMAN PRESCRIPTION DRUG LABEL 1 80603-103 CAPSULE, LIQUID FILLED 150 mg ORAL NDA 36 sections
Kyzatrex HUMAN PRESCRIPTION DRUG LABEL 1 80603-103 CAPSULE, LIQUID FILLED 150 mg ORAL NDA 36 sections
Kyzatrex HUMAN PRESCRIPTION DRUG LABEL 1 80603-105 CAPSULE, LIQUID FILLED 200 mg ORAL NDA 36 sections
Kyzatrex HUMAN PRESCRIPTION DRUG LABEL 1 80603-105 CAPSULE, LIQUID FILLED 200 mg ORAL NDA 36 sections