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dexmethylphenidate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 836 | 40431-64-9 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A methylphenidate derivative, DOPAMINE UPTAKE INHIBITOR and CENTRAL NERVOUS SYSTEM STIMULANT that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 15 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 0.50 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 1.06 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| Vd (Volume of distribution) | 2.65 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 6.67 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.87 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 8 hours | Lombardo F, Berellini G, Obach RS |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 0.253 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 1.954 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 9.376 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 8.630 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 81.470 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 65.690 | % | High | 1 |
| herg | hERG pIC50 | 4.524 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 4.295 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 11.776 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 77.700 | % | High | 1 |
| kinase-safety-class | ACVR2B,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,MAP3K7,MAPK7,MET,NTRK2,PDK2,PDK4,PIK3CB,PRKDC,TEK,TGFBR1 | 23 | |||
| kinase-selectivity-class | AXL,EIF2AK3,GRK2,PDK4 | 4 | |||
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 1.837 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 97.724 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 78.480 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 3.133 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 82.120 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 84.333 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 91.950 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 74.390 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 851.138 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Nov. 13, 2001 | FDA | NOVARTIS |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Adulterated product | 105.71 | 28.15 | 17 | 2860 | 377 | 90625193 |
| Claustrophobia | 103.37 | 28.15 | 20 | 2857 | 1307 | 90624263 |
| Product tampering | 102.97 | 28.15 | 17 | 2860 | 446 | 90625124 |
| Pulse abnormal | 86.59 | 28.15 | 20 | 2857 | 3059 | 90622511 |
| Somatic symptom disorder | 84.38 | 28.15 | 20 | 2857 | 3421 | 90622149 |
| Mood swings | 74.10 | 28.15 | 27 | 2850 | 20675 | 90604895 |
| Hyperreflexia | 71.28 | 28.15 | 20 | 2857 | 6637 | 90618933 |
| Disturbance in attention | 70.77 | 28.15 | 33 | 2844 | 47076 | 90578494 |
| Neurological symptom | 70.72 | 28.15 | 20 | 2857 | 6827 | 90618743 |
| Paranoia | 70.14 | 28.15 | 23 | 2854 | 12885 | 90612685 |
| Brain injury | 68.31 | 28.15 | 20 | 2857 | 7718 | 90617852 |
| Suicidal ideation | 67.63 | 28.15 | 37 | 2840 | 73818 | 90551752 |
| Amenorrhoea | 60.13 | 28.15 | 20 | 2857 | 11702 | 90613868 |
| Withdrawal syndrome | 54.18 | 28.15 | 22 | 2855 | 22502 | 90603068 |
| Hypertensive crisis | 51.98 | 28.15 | 20 | 2857 | 17764 | 90607806 |
| Feeling abnormal | 48.34 | 28.15 | 41 | 2836 | 167194 | 90458376 |
| Product substitution issue | 44.72 | 28.15 | 18 | 2859 | 17990 | 90607580 |
| Intentional product misuse | 43.65 | 28.15 | 30 | 2847 | 89574 | 90535996 |
| Hypophagia | 38.48 | 28.15 | 20 | 2857 | 35917 | 90589653 |
| Palpitations | 38.43 | 28.15 | 33 | 2844 | 136695 | 90488875 |
| Abnormal behaviour | 37.55 | 28.15 | 17 | 2860 | 22611 | 90602959 |
| Illness | 32.00 | 28.15 | 24 | 2853 | 81945 | 90543625 |
| Supraventricular tachycardia | 29.43 | 28.15 | 13 | 2864 | 16323 | 90609247 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Product substitution issue | 229.80 | 32.59 | 65 | 2627 | 11225 | 42607418 |
| Abnormal behaviour | 182.80 | 32.59 | 67 | 2625 | 26384 | 42592259 |
| Drug ineffective | 103.73 | 32.59 | 159 | 2533 | 630038 | 41988605 |
| Aggression | 83.26 | 32.59 | 45 | 2647 | 44118 | 42574525 |
| Anger | 82.51 | 32.59 | 31 | 2661 | 12987 | 42605656 |
| Tic | 73.14 | 32.59 | 19 | 2673 | 2364 | 42616279 |
| Agitation | 62.80 | 32.59 | 43 | 2649 | 64271 | 42554372 |
| Irritability | 62.46 | 32.59 | 32 | 2660 | 28096 | 42590547 |
| Psychomotor hyperactivity | 58.37 | 32.59 | 23 | 2669 | 10935 | 42607708 |
| Disturbance in attention | 57.82 | 32.59 | 31 | 2661 | 29835 | 42588808 |
| Brugada syndrome | 55.68 | 32.59 | 13 | 2679 | 1040 | 42617603 |
| Attention deficit hyperactivity disorder | 54.65 | 32.59 | 16 | 2676 | 3092 | 42615551 |
| Product quality issue | 44.54 | 32.59 | 22 | 2670 | 17860 | 42600783 |
| Crying | 43.32 | 32.59 | 16 | 2676 | 6378 | 42612265 |
| Suicidal ideation | 41.84 | 32.59 | 30 | 2662 | 48131 | 42570512 |
| Anxiety | 41.66 | 32.59 | 44 | 2648 | 118516 | 42500127 |
| Emotional disorder | 39.85 | 32.59 | 15 | 2677 | 6299 | 42612344 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Product substitution issue | 232.44 | 29.77 | 69 | 4211 | 22992 | 110562027 |
| Abnormal behaviour | 102.70 | 29.77 | 43 | 4237 | 38996 | 110546023 |
| Product tampering | 99.01 | 29.77 | 17 | 4263 | 462 | 110584557 |
| Claustrophobia | 95.92 | 29.77 | 20 | 4260 | 1559 | 110583460 |
| Disturbance in attention | 92.48 | 29.77 | 46 | 4234 | 61949 | 110523070 |
| Adulterated product | 84.08 | 29.77 | 17 | 4263 | 1138 | 110583881 |
| Somatic symptom disorder | 82.12 | 29.77 | 20 | 4260 | 3139 | 110581880 |
| Anger | 82.08 | 29.77 | 30 | 4250 | 18977 | 110566042 |
| Tic | 80.12 | 29.77 | 20 | 4260 | 3473 | 110581546 |
| Suicidal ideation | 77.15 | 29.77 | 47 | 4233 | 93890 | 110491129 |
| Pulse abnormal | 76.70 | 29.77 | 20 | 4260 | 4129 | 110580890 |
| Mood swings | 73.24 | 29.77 | 29 | 4251 | 22783 | 110562236 |
| Irritability | 66.95 | 29.77 | 34 | 4246 | 47775 | 110537244 |
| Hyperreflexia | 64.40 | 29.77 | 21 | 4259 | 9464 | 110575555 |
| Aggression | 62.83 | 29.77 | 35 | 4245 | 59175 | 110525844 |
| Amenorrhoea | 60.90 | 29.77 | 20 | 4260 | 9211 | 110575808 |
| Withdrawal syndrome | 58.03 | 29.77 | 27 | 4253 | 31353 | 110553666 |
| Brugada syndrome | 56.69 | 29.77 | 13 | 4267 | 1575 | 110583444 |
| Paranoia | 56.66 | 29.77 | 24 | 4256 | 22350 | 110562669 |
| Neurological symptom | 54.17 | 29.77 | 21 | 4259 | 15587 | 110569432 |
| Brain injury | 53.50 | 29.77 | 20 | 4260 | 13456 | 110571563 |
| Agitation | 46.49 | 29.77 | 37 | 4243 | 113014 | 110472005 |
| Hypertensive crisis | 42.07 | 29.77 | 20 | 4260 | 24352 | 110560667 |
| Product dose omission issue | 40.86 | 29.77 | 56 | 4224 | 321726 | 110263293 |
| Psychomotor hyperactivity | 36.10 | 29.77 | 17 | 4263 | 20260 | 110564759 |
| Hyperhidrosis | 35.70 | 29.77 | 40 | 4240 | 187258 | 110397761 |
| Educational problem | 33.62 | 29.77 | 7 | 4273 | 541 | 110584478 |
| Feeling abnormal | 31.74 | 29.77 | 37 | 4243 | 180674 | 110404345 |
| Loss of consciousness | 30.88 | 29.77 | 38 | 4242 | 196268 | 110388751 |
| Palpitations | 30.32 | 29.77 | 34 | 4246 | 159178 | 110425841 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N06BA11 | NERVOUS SYSTEM PSYCHOANALEPTICS PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS Centrally acting sympathomimetics |
| ATC | N06BA15 | NERVOUS SYSTEM PSYCHOANALEPTICS PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS Centrally acting sympathomimetics |
| FDA PE | N0000175729 | Central Nervous System Stimulation |
| FDA EPC | N0000175739 | Central Nervous System Stimulant |
| MeSH PA | D000697 | Central Nervous System Stimulants |
| MeSH PA | D014179 | Neurotransmitter Uptake Inhibitors |
| MeSH PA | D015259 | Dopamine Agents |
| MeSH PA | D018377 | Neurotransmitter Agents |
| MeSH PA | D018765 | Dopamine Uptake Inhibitors |
| MeSH PA | D049990 | Membrane Transport Modulators |
| CHEBI has role | CHEBI:37962 | adrenergic agent |
Related Drugs by ATC class:
N06BA Centrally acting sympathomimetics 14 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Attention deficit hyperactivity disorder | indication | 406506008 | |
| Gilles de la Tourette's syndrome | contraindication | 5158005 | DOID:11119 |
| Dependent drug abuse | contraindication | 6525002 | |
| Alcoholism | contraindication | 7200002 | |
| Sinus tachycardia | contraindication | 11092001 | |
| Bipolar disorder | contraindication | 13746004 | DOID:3312 |
| Myocardial infarction | contraindication | 22298006 | DOID:5844 |
| Glaucoma | contraindication | 23986001 | DOID:1686 |
| Feeling agitated | contraindication | 24199005 | |
| Hypertensive disorder | contraindication | 38341003 | DOID:10763 |
| Chronic heart failure | contraindication | 48447003 | |
| Tension | contraindication | 53489000 | |
| Aggressive behavior | contraindication | 61372001 | |
| Psychotic disorder | contraindication | 69322001 | |
| Severe anxiety (panic) | contraindication | 80583007 | |
| Leukopenia | contraindication | 84828003 | DOID:615 |
| Cardiomyopathy | contraindication | 85898001 | DOID:0050700 |
| Structural disorder of heart | contraindication | 128599005 | |
| Seizure disorder | contraindication | 128613002 | |
| Motor tic disorder | contraindication | 230337001 | |
| Cerebrovascular accident | contraindication | 230690007 | |
| Mania | contraindication | 231494001 | |
| Anemia | contraindication | 271737000 | DOID:2355 |
| Thrombocytopenic disorder | contraindication | 302215000 | DOID:1588 |
| Visual impairment | contraindication | 397540003 | |
| Disorder of coronary artery | contraindication | 414024009 | |
| Life-Threatening Cardiac Arrhythmias | contraindication |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 8.68 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 10.4MG BASE;EQ 52.3MG BASE | AZSTARYS | COMMAVE SUB | N212994 | May 7, 2021 | RX | CAPSULE | ORAL | 10858341 | Dec. 9, 2037 | TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE |
| EQ 10.4MG BASE;EQ 52.3MG BASE | AZSTARYS | COMMAVE SUB | N212994 | May 7, 2021 | RX | CAPSULE | ORAL | 10954213 | Dec. 9, 2037 | TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE |
| EQ 5.2MG BASE;EQ 26.1MG BASE | AZSTARYS | COMMAVE SUB | N212994 | May 7, 2021 | RX | CAPSULE | ORAL | 10858341 | Dec. 9, 2037 | TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE |
| EQ 5.2MG BASE;EQ 26.1MG BASE | AZSTARYS | COMMAVE SUB | N212994 | May 7, 2021 | RX | CAPSULE | ORAL | 10954213 | Dec. 9, 2037 | TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE |
| EQ 7.8MG BASE;EQ 39.2MG BASE | AZSTARYS | COMMAVE SUB | N212994 | May 7, 2021 | RX | CAPSULE | ORAL | 10858341 | Dec. 9, 2037 | TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE |
| EQ 7.8MG BASE;EQ 39.2MG BASE | AZSTARYS | COMMAVE SUB | N212994 | May 7, 2021 | RX | CAPSULE | ORAL | 10954213 | Dec. 9, 2037 | TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD) WITH SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 10.4MG BASE;EQ 52.3MG BASE | AZSTARYS | COMMAVE SUB | N212994 | May 7, 2021 | RX | CAPSULE | ORAL | May 7, 2026 | NEW CHEMICAL ENTITY |
| EQ 5.2MG BASE;EQ 26.1MG BASE | AZSTARYS | COMMAVE SUB | N212994 | May 7, 2021 | RX | CAPSULE | ORAL | May 7, 2026 | NEW CHEMICAL ENTITY |
| EQ 7.8MG BASE;EQ 39.2MG BASE | AZSTARYS | COMMAVE SUB | N212994 | May 7, 2021 | RX | CAPSULE | ORAL | May 7, 2026 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Sodium-dependent noradrenaline transporter | Transporter | INHIBITOR | WOMBAT-PK | CHEMBL | |||||
| Sodium-dependent dopamine transporter | Transporter | INHIBITOR | Ki | 7.80 | CHEMBL | CHEMBL | |||
| Sodium-dependent dopamine transporter | Transporter | Ki | 7.13 | CHEMBL | |||||
| Transporter | Transporter | Ki | 6.57 | CHEMBL | |||||
| Dopamine receptor | GPCR | IC50 | 7.08 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| D03721 | KEGG_DRUG |
| 19262-68-1 | SECONDARY_CAS_RN |
| 352372 | RXNORM |
| 4021285 | VANDF |
| 4028927 | VANDF |
| C1169997 | UMLSCUI |
| CHEBI:51860 | CHEBI |
| A1D5U | PDB_CHEM_ID |
| CHEMBL827 | ChEMBL_ID |
| DB06701 | DRUGBANK_ID |
| CHEMBL904 | ChEMBL_ID |
| D064699 | MESH_DESCRIPTOR_UI |
| 154101 | PUBCHEM_CID |
| 7554 | IUPHAR_LIGAND_ID |
| 8289 | INN_ID |
| M32RH9MFGP | UNII |
| 110936 | MMSL |
| 16208 | MMSL |
| 39360 | MMSL |
| 42461 | MMSL |
| d04777 | MMSL |
| 009511 | NDDF |
| 009512 | NDDF |
| 385555005 | SNOMEDCT_US |
| 767702004 | SNOMEDCT_US |
| 767715008 | SNOMEDCT_US |
| M32RH9MFGP | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Focalin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0380 | TABLET | 2.50 mg | ORAL | NDA | 32 sections |
| Focalin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0381 | TABLET | 5 mg | ORAL | NDA | 32 sections |
| Focalin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0382 | TABLET | 10 mg | ORAL | NDA | 32 sections |
| FocalinXR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0430 | CAPSULE, EXTENDED RELEASE | 5 mg | ORAL | NDA | 32 sections |
| FocalinXR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0430 | CAPSULE, EXTENDED RELEASE | 5 mg | ORAL | NDA | 32 sections |
| FocalinXR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0431 | CAPSULE, EXTENDED RELEASE | 10 mg | ORAL | NDA | 32 sections |
| FocalinXR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0431 | CAPSULE, EXTENDED RELEASE | 10 mg | ORAL | NDA | 32 sections |
| FocalinXR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0432 | CAPSULE, EXTENDED RELEASE | 20 mg | ORAL | NDA | 32 sections |
| FocalinXR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0432 | CAPSULE, EXTENDED RELEASE | 20 mg | ORAL | NDA | 32 sections |
| FocalinXR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0433 | CAPSULE, EXTENDED RELEASE | 30 mg | ORAL | NDA | 32 sections |
| FocalinXR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0433 | CAPSULE, EXTENDED RELEASE | 30 mg | ORAL | NDA | 32 sections |
| FocalinXR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0434 | CAPSULE, EXTENDED RELEASE | 40 mg | ORAL | NDA | 32 sections |
| FocalinXR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0434 | CAPSULE, EXTENDED RELEASE | 40 mg | ORAL | NDA | 32 sections |
| FocalinXR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0493 | CAPSULE, EXTENDED RELEASE | 15 mg | ORAL | NDA | 32 sections |
| FocalinXR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0493 | CAPSULE, EXTENDED RELEASE | 15 mg | ORAL | NDA | 32 sections |
| FocalinXR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0608 | CAPSULE, EXTENDED RELEASE | 25 mg | ORAL | NDA | 32 sections |
| FocalinXR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0608 | CAPSULE, EXTENDED RELEASE | 25 mg | ORAL | NDA | 32 sections |
| FocalinXR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0609 | CAPSULE, EXTENDED RELEASE | 35 mg | ORAL | NDA | 32 sections |
| FocalinXR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0078-0609 | CAPSULE, EXTENDED RELEASE | 35 mg | ORAL | NDA | 32 sections |
| Dexmethylphenidate Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-5045 | CAPSULE, EXTENDED RELEASE | 25 mg | ORAL | ANDA | 29 sections |
| Dexmethylphenidate Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-5046 | CAPSULE, EXTENDED RELEASE | 35 mg | ORAL | ANDA | 29 sections |
| Dexmethylphenidate Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-5550 | CAPSULE, EXTENDED RELEASE | 5 mg | ORAL | ANDA | 29 sections |
| Dexmethylphenidate Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-5551 | CAPSULE, EXTENDED RELEASE | 10 mg | ORAL | ANDA | 29 sections |
| Dexmethylphenidate Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-5552 | CAPSULE, EXTENDED RELEASE | 15 mg | ORAL | ANDA | 29 sections |
| Dexmethylphenidate Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-5553 | CAPSULE, EXTENDED RELEASE | 20 mg | ORAL | ANDA | 29 sections |
| Dexmethylphenidate Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-5554 | CAPSULE, EXTENDED RELEASE | 30 mg | ORAL | ANDA | 29 sections |
| Dexmethylphenidate Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-5562 | CAPSULE, EXTENDED RELEASE | 40 mg | ORAL | ANDA | 29 sections |
| Dexmethylphenidate hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0115-1709 | CAPSULE, EXTENDED RELEASE | 25 mg | ORAL | ANDA | 21 sections |
| Dexmethylphenidate hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0115-1709 | CAPSULE, EXTENDED RELEASE | 25 mg | ORAL | ANDA | 21 sections |
| Dexmethylphenidate hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0115-1710 | CAPSULE, EXTENDED RELEASE | 35 mg | ORAL | ANDA | 21 sections |