aripiprazole lauroxil 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
psychotropics, phenylpiperazine derivatives 5052 1259305-29-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • aripiprazole lauroxil
  • aristada
  • RDC-3317
prodrug of aripiprazole, following intramuscular injection is converted by enzyme-mediated hydrolysis to N-hydroxymethyl aripiprazole which is then hydrolyzed to aripiprazole
  • Molecular weight: 660.72
  • Formula: C36H51Cl2N3O4
  • CLOGP: 10.60
  • LIPINSKI: 2
  • HAC: 7
  • HDO: 0
  • TPSA: 62.32
  • ALOGS: -6.44
  • ROTB: 20

  • Status: ONP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Oct. 5, 2015 FDA ALKERMES

FDA Adverse Event Reporting System (Female)

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
Needle issue 476.68 45.15 103 2223 10273 63476423
Off label use 298.82 45.15 222 2104 674240 62812456
Injection site pain 271.78 45.15 119 2207 129681 63357015
Injection site mass 200.97 45.15 58 2268 18598 63468098
Hallucination, auditory 138.58 45.15 40 2286 12784 63473912
Product administered at inappropriate site 131.58 45.15 29 2297 3120 63483576
Syringe issue 112.03 45.15 25 2301 2844 63483852
Injection site induration 105.11 45.15 30 2296 9196 63477500
Therapeutic response shortened 89.18 45.15 28 2298 11860 63474836
Weight increased 69.85 45.15 65 2261 260727 63225969
Product administration error 61.36 45.15 25 2301 22372 63464324
Paranoia 53.58 45.15 19 2307 11660 63475036
Inappropriate schedule of product administration 53.47 45.15 38 2288 103927 63382769
Wrong technique in device usage process 51.49 45.15 14 2312 3584 63483112
Product physical consistency issue 49.72 45.15 10 2316 689 63486007

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
Needle issue 364.78 58.59 85 2396 6080 34948370
Product administered at inappropriate site 333.05 58.59 66 2415 2170 34952280
Injection site pain 322.70 58.59 116 2365 38889 34915561
Hallucination, auditory 197.27 58.59 60 2421 11857 34942593
Off label use 163.64 58.59 172 2309 419352 34535098
Therapeutic response shortened 151.72 58.59 44 2437 7360 34947090
Injection site mass 70.96 58.59 24 2457 6602 34947848
Syringe issue 70.58 58.59 23 2458 5641 34948809
Product dose omission issue 70.31 58.59 62 2419 119649 34834801
Underdose 60.39 58.59 26 2455 13754 34940696
Wrong technique in device usage process 59.25 58.59 15 2466 1497 34952953

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
Needle issue 665.63 52.01 151 4071 12917 79727249
Injection site pain 506.08 52.01 206 4016 129632 79610534
Product administered at inappropriate site 343.29 52.01 71 4151 3894 79736272
Off label use 334.18 52.01 315 3907 906900 78833266
Hallucination, auditory 295.57 52.01 87 4135 20606 79719560
Injection site mass 237.04 52.01 73 4149 20111 79720055
Therapeutic response shortened 188.86 52.01 58 4164 15805 79724361
Syringe issue 123.71 52.01 34 4188 6264 79733902
Injection site induration 121.49 52.01 37 4185 9782 79730384
Weight increased 121.20 52.01 107 4115 277279 79462887
Product dose omission issue 113.14 52.01 98 4124 247439 79492727
Inappropriate schedule of product administration 91.13 52.01 67 4155 133561 79606605
Wrong technique in device usage process 80.27 52.01 22 4200 4006 79736160
Anxiety 76.28 52.01 79 4143 248433 79491733
Paranoia 72.31 52.01 30 4192 19402 79720764
Restlessness 68.61 52.01 38 4184 46454 79693712
Underdose 65.69 52.01 33 4189 33118 79707048
Product physical consistency issue 65.56 52.01 14 4208 891 79739275
Soliloquy 63.62 52.01 13 4209 667 79739499
Anger 58.85 52.01 25 4197 17137 79723029
Incorrect dose administered 58.06 52.01 41 4181 76589 79663577
Product administration error 55.28 52.01 29 4193 31817 79708349
Hospitalisation 54.78 52.01 43 4179 94193 79645973

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
MeSH PA D014150 Antipsychotic Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D011619 Psychotropic Drugs
MeSH PA D014149 Tranquilizing Agents
CHEBI has role CHEBI:35941 serotonin agonists
CHEBI has role CHEBI:37955 H1 receptor antagonists
CHEBI has role CHEBI:50266 Prodrugs
CHEBI has role CHEBI:65191 atypical antipsychotic agent

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

DiseaseRelationSNOMED_IDDOID
Schizophrenia indication 58214004 DOID:5419




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 7.84 Basic
pKa2 0.67 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
1064MG/3.9ML (272.82MG/ML) ARISTADA ALKERMES INC N207533 June 5, 2017 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10112903 June 24, 2030 TREATMENT OF SCHIZOPHRENIA
1064MG/3.9ML (272.82MG/ML) ARISTADA ALKERMES INC N207533 June 5, 2017 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 8796276 June 24, 2030 TREATMENT OF SCHIZOPHRENIA
441MG/1.6ML (275.63MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10112903 June 24, 2030 TREATMENT OF SCHIZOPHRENIA
441MG/1.6ML (275.63MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 8796276 June 24, 2030 TREATMENT OF SCHIZOPHRENIA
662MG/2.4ML (275.83MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10112903 June 24, 2030 TREATMENT OF SCHIZOPHRENIA
662MG/2.4ML (275.83MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 8796276 June 24, 2030 TREATMENT OF SCHIZOPHRENIA
882MG/3.2ML (275.63MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10112903 June 24, 2030 TREATMENT OF SCHIZOPHRENIA
882MG/3.2ML (275.63MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 8796276 June 24, 2030 TREATMENT OF SCHIZOPHRENIA
675MG/2.4ML ARISTADA INITIO KIT ALKERMES INC N209830 June 29, 2018 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10112903 June 24, 2030 TREATMENT OF SCHIZOPHRENIA
675MG/2.4ML ARISTADA INITIO KIT ALKERMES INC N209830 June 29, 2018 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 8796276 June 24, 2030 TREATMENT OF SCHIZOPHRENIA
1064MG/3.9ML (272.82MG/ML) ARISTADA ALKERMES INC N207533 June 5, 2017 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10226458 March 19, 2032 TREATMENT OF SCHIZOPHRENIA
441MG/1.6ML (275.63MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10226458 March 19, 2032 TREATMENT OF SCHIZOPHRENIA
662MG/2.4ML (275.83MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10226458 March 19, 2032 TREATMENT OF SCHIZOPHRENIA
882MG/3.2ML (275.63MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10226458 March 19, 2032 TREATMENT OF SCHIZOPHRENIA
1064MG/3.9ML (272.82MG/ML) ARISTADA ALKERMES INC N207533 June 5, 2017 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9034867 Nov. 7, 2032 TREATMENT OF SCHIZOPHRENIA
441MG/1.6ML (275.63MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9034867 Nov. 7, 2032 TREATMENT OF SCHIZOPHRENIA
662MG/2.4ML (275.83MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9034867 Nov. 7, 2032 TREATMENT OF SCHIZOPHRENIA
882MG/3.2ML (275.63MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9034867 Nov. 7, 2032 TREATMENT OF SCHIZOPHRENIA
1064MG/3.9ML (272.82MG/ML) ARISTADA ALKERMES INC N207533 June 5, 2017 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11097006 Oct. 24, 2033 TREATMENT OF SCHIZOPHRENIA
1064MG/3.9ML (272.82MG/ML) ARISTADA ALKERMES INC N207533 June 5, 2017 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9193685 Oct. 24, 2033 TREATMENT OF SCHIZOPHRENIA
441MG/1.6ML (275.63MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11097006 Oct. 24, 2033 TREATMENT OF SCHIZOPHRENIA
441MG/1.6ML (275.63MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9193685 Oct. 24, 2033 TREATMENT OF SCHIZOPHRENIA
662MG/2.4ML (275.83MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11097006 Oct. 24, 2033 TREATMENT OF SCHIZOPHRENIA
662MG/2.4ML (275.83MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9193685 Oct. 24, 2033 TREATMENT OF SCHIZOPHRENIA
882MG/3.2ML (275.63MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11097006 Oct. 24, 2033 TREATMENT OF SCHIZOPHRENIA
882MG/3.2ML (275.63MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9193685 Oct. 24, 2033 TREATMENT OF SCHIZOPHRENIA
1064MG/3.9ML (272.82MG/ML) ARISTADA ALKERMES INC N207533 June 5, 2017 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10238651 March 19, 2035 TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION
1064MG/3.9ML (272.82MG/ML) ARISTADA ALKERMES INC N207533 June 5, 2017 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10813928 March 19, 2035 TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INJECTION
1064MG/3.9ML (272.82MG/ML) ARISTADA ALKERMES INC N207533 June 5, 2017 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11406632 March 19, 2035 TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION
1064MG/3.9ML (272.82MG/ML) ARISTADA ALKERMES INC N207533 June 5, 2017 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9452131 March 19, 2035 TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION
441MG/1.6ML (275.63MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10238651 March 19, 2035 TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION
441MG/1.6ML (275.63MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10813928 March 19, 2035 TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INJECTION
441MG/1.6ML (275.63MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11406632 March 19, 2035 TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION
441MG/1.6ML (275.63MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9452131 March 19, 2035 TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION
662MG/2.4ML (275.83MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10238651 March 19, 2035 TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION
662MG/2.4ML (275.83MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10813928 March 19, 2035 TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INJECTION
662MG/2.4ML (275.83MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11406632 March 19, 2035 TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION
662MG/2.4ML (275.83MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9452131 March 19, 2035 TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION
882MG/3.2ML (275.63MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10238651 March 19, 2035 TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION
882MG/3.2ML (275.63MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10813928 March 19, 2035 TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION
882MG/3.2ML (275.63MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11406632 March 19, 2035 TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION
882MG/3.2ML (275.63MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 9452131 March 19, 2035 TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION
675MG/2.4ML ARISTADA INITIO KIT ALKERMES INC N209830 June 29, 2018 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 10849894 Aug. 17, 2035 TREATMENT OF SCHIZOPHRENIA
1064MG/3.9ML (272.82MG/ML) ARISTADA ALKERMES INC N207533 June 5, 2017 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11273158 April 6, 2039 TREATMENT OF SCHIZOPHRENIA
441MG/1.6ML (275.63MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11273158 April 6, 2039 TREATMENT OF SCHIZOPHRENIA
662MG/2.4ML (275.83MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11273158 April 6, 2039 TREATMENT OF SCHIZOPHRENIA
882MG/3.2ML (275.63MG/ML) ARISTADA ALKERMES INC N207533 Oct. 5, 2015 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11273158 April 6, 2039 TREATMENT OF SCHIZOPHRENIA
675MG/2.4ML ARISTADA INITIO KIT ALKERMES INC N209830 June 29, 2018 RX SUSPENSION, EXTENDED RELEASE INTRAMUSCULAR 11273158 April 6, 2039 TREATMENT OF SCHIZOPHRENIA

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
D(2) dopamine receptor GPCR PARTIAL AGONIST Ki 9.47 DRUG LABEL DRUG LABEL
5-hydroxytryptamine receptor 1A GPCR PARTIAL AGONIST Ki 8.77 DRUG LABEL DRUG LABEL
5-hydroxytryptamine receptor 2A GPCR ANTAGONIST Ki 8.47 DRUG LABEL DRUG LABEL
5-hydroxytryptamine receptor 1B GPCR AGONIST Ki 6.10 IUPHAR
5-hydroxytryptamine receptor 7 GPCR Ki 7.41 DRUG LABEL
D(3) dopamine receptor GPCR Ki 9.10 DRUG LABEL
Histamine H1 receptor GPCR Ki 7.22 DRUG LABEL
D(4) dopamine receptor GPCR Ki 7.36 DRUG LABEL
5-hydroxytryptamine receptor 2C GPCR Ki 7.82 DRUG LABEL
5-hydroxytryptamine receptor 1D GPCR AGONIST Ki 7.20 IUPHAR
5-hydroxytryptamine receptor 2A GPCR AGONIST Ki 7.70 IUPHAR
5-hydroxytryptamine receptor 7 GPCR AGONIST Ki 7.80 IUPHAR
D(4) dopamine receptor GPCR ANTAGONIST Ki 7.30 IUPHAR
5-hydroxytryptamine receptor 6 GPCR AGONIST Ki 6.80 IUPHAR
D(2) dopamine receptor GPCR AGONIST Ki 9.70 IUPHAR

External reference:

IDSource
B786J7A343 UNII
D10364 KEGG_DRUG
4034891 VANDF
C4056439 UMLSCUI
CHEBI:90930 CHEBI
CHEMBL2219425 ChEMBL_ID
49831411 PUBCHEM_CID
DB14185 DRUGBANK_ID
C000603935 MESH_SUPPLEMENTAL_RECORD_UI
1673265 RXNORM
236432 MMSL
31226 MMSL
016489 NDDF
017628 NDDF
715182007 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
ARISTADA HUMAN PRESCRIPTION DRUG LABEL 1 65757-401 INJECTION, SUSPENSION, EXTENDED RELEASE 441 mg INTRAMUSCULAR NDA 29 sections
ARISTADA HUMAN PRESCRIPTION DRUG LABEL 1 65757-401 INJECTION, SUSPENSION, EXTENDED RELEASE 441 mg INTRAMUSCULAR NDA 29 sections
ARISTADA HUMAN PRESCRIPTION DRUG LABEL 1 65757-402 INJECTION, SUSPENSION, EXTENDED RELEASE 662 mg INTRAMUSCULAR NDA 29 sections
ARISTADA HUMAN PRESCRIPTION DRUG LABEL 1 65757-402 INJECTION, SUSPENSION, EXTENDED RELEASE 662 mg INTRAMUSCULAR NDA 29 sections
ARISTADA HUMAN PRESCRIPTION DRUG LABEL 1 65757-403 INJECTION, SUSPENSION, EXTENDED RELEASE 882 mg INTRAMUSCULAR NDA 29 sections
ARISTADA HUMAN PRESCRIPTION DRUG LABEL 1 65757-403 INJECTION, SUSPENSION, EXTENDED RELEASE 882 mg INTRAMUSCULAR NDA 29 sections
ARISTADA HUMAN PRESCRIPTION DRUG LABEL 1 65757-404 INJECTION, SUSPENSION, EXTENDED RELEASE 1064 mg INTRAMUSCULAR NDA 29 sections
ARISTADA HUMAN PRESCRIPTION DRUG LABEL 1 65757-404 INJECTION, SUSPENSION, EXTENDED RELEASE 1064 mg INTRAMUSCULAR NDA 29 sections
ARISTADA INITIO HUMAN PRESCRIPTION DRUG LABEL 1 65757-500 INJECTION, SUSPENSION, EXTENDED RELEASE 675 mg INTRAMUSCULAR NDA 29 sections
ARISTADA INITIO HUMAN PRESCRIPTION DRUG LABEL 1 65757-500 INJECTION, SUSPENSION, EXTENDED RELEASE 675 mg INTRAMUSCULAR NDA 29 sections