deutetrabenazine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 5226 | 1392826-25-3 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
The precise mechanism by which deutetrabenazine exerts its anti-chorea effects is unknown but is believed to be related to its effect as a reversible depletor of monoamines (such as dopamine, serotonin, norepinephrine, and histamine) from nerve terminals. The major circulating metabolites (alpha-dihydrotetrabenazine [HTBZ] and beta-HTBZ) of deutetrabenazine, are reversible inhibitors of VMAT2, resulting in decreased uptake of monoamines into synaptic vesicles and depletion of monoamine stores.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| S (Water solubility) | 0.34 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Bocci G, Oprea TI, Benet LZ |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| April 3, 2017 | FDA | TEVA PHARMS USA INC |
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 |
|---|---|---|---|---|---|---|
| Dyskinesia | 105.78 | 36.81 | 35 | 1249 | 31967 | 63455771 |
| Depression | 78.87 | 36.81 | 49 | 1235 | 196443 | 63291295 |
| Therapy cessation | 57.46 | 36.81 | 22 | 1262 | 30435 | 63457303 |
| Tremor | 43.07 | 36.81 | 29 | 1255 | 132210 | 63355528 |
| Suicidal ideation | 39.46 | 36.81 | 21 | 1263 | 62400 | 63425338 |
FDA Adverse Event Reporting System (Male)
None
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 |
|---|---|---|---|---|---|---|
| Dyskinesia | 73.44 | 36.36 | 27 | 1181 | 44746 | 79698434 |
| Depression | 58.83 | 36.36 | 38 | 1170 | 216752 | 79526428 |
| Therapy cessation | 48.37 | 36.36 | 19 | 1189 | 37543 | 79705637 |
| Tardive dyskinesia | 44.39 | 36.36 | 13 | 1195 | 10558 | 79732622 |
| Suicidal ideation | 44.14 | 36.36 | 22 | 1186 | 76318 | 79666862 |
| Parkinsonism | 42.62 | 36.36 | 14 | 1194 | 16570 | 79726610 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N07XX16 | NERVOUS SYSTEM OTHER NERVOUS SYSTEM DRUGS OTHER NERVOUS SYSTEM DRUGS Other nervous system drugs |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Huntington's chorea | indication | 58756001 | DOID:12858 |
| Tardive dyskinesia | indication | 102449007 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 8.01 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 12MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 9550780 | Sept. 18, 2033 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 12MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 9550780 | Sept. 18, 2033 | TREATMENT OF TARDIVE DYSKINESIA |
| 6MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 9550780 | Sept. 18, 2033 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 6MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 9550780 | Sept. 18, 2033 | TREATMENT OF TARDIVE DYSKINESIA |
| 9MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 9550780 | Sept. 18, 2033 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 9MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 9550780 | Sept. 18, 2033 | TREATMENT OF TARDIVE DYSKINESIA |
| 12MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 9550780 | Sept. 18, 2033 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 12MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 9550780 | Sept. 18, 2033 | TREATMENT OF TARDIVE DYSKINESIA |
| 24MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 9550780 | Sept. 18, 2033 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 24MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 9550780 | Sept. 18, 2033 | TREATMENT OF TARDIVE DYSKINESIA |
| 6MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 9550780 | Sept. 18, 2033 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 6MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 9550780 | Sept. 18, 2033 | TREATMENT OF TARDIVE DYSKINESIA |
| 12MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 10959996 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 12MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11357772 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 12MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11357772 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 12MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11446291 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 12MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11564917 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 12MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11648244 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 6MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 10959996 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 6MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11357772 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 6MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11357772 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 6MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11446291 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 6MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11564917 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 6MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11648244 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 9MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 10959996 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 9MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11357772 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 9MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11357772 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 9MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11446291 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 9MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11564917 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 9MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11648244 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 12MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 10959996 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 12MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11357772 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 12MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11357772 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 12MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11446291 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 12MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11564917 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 12MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11648244 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 24MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 10959996 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 24MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11357772 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 24MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11357772 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 24MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11446291 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 24MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11564917 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 24MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11648244 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 6MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 10959996 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 6MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11357772 | March 7, 2036 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 6MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11357772 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 6MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11446291 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 6MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11564917 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 6MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11648244 | March 7, 2036 | TREATMENT OF TARDIVE DYSKINESIA |
| 12MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11179386 | March 15, 2038 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 12MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11179386 | March 15, 2038 | TREATMENT OF TARDIVE DYSKINESIA |
| 6MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11179386 | March 15, 2038 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 6MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11179386 | March 15, 2038 | TREATMENT OF TARDIVE DYSKINESIA |
| 9MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11179386 | March 15, 2038 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 9MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | 11179386 | March 15, 2038 | TREATMENT OF TARDIVE DYSKINESIA |
| 12MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11179386 | March 15, 2038 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 12MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11179386 | March 15, 2038 | TREATMENT OF TARDIVE DYSKINESIA |
| 24MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11179386 | March 15, 2038 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 24MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11179386 | March 15, 2038 | TREATMENT OF TARDIVE DYSKINESIA |
| 6MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11179386 | March 15, 2038 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 6MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11179386 | March 15, 2038 | TREATMENT OF TARDIVE DYSKINESIA |
| 12MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11311488 | June 10, 2041 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 12MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11311488 | June 10, 2041 | TREATMENT OF TARDIVE DYSKINESIA |
| 24MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11311488 | June 10, 2041 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 24MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11311488 | June 10, 2041 | TREATMENT OF TARDIVE DYSKINESIA |
| 6MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11311488 | June 10, 2041 | A METHOD OF TREATING HUNTINGTONS CHOREA |
| 6MG | AUSTEDO XR | TEVA | N216354 | Feb. 17, 2023 | RX | TABLET, EXTENDED RELEASE | ORAL | 11311488 | June 10, 2041 | TREATMENT OF TARDIVE DYSKINESIA |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 12MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | April 3, 2024 | TREATMENT OF CHOREA ASSOCIATED WITH HUNTINGTONS DISEASE |
| 6MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | April 3, 2024 | TREATMENT OF CHOREA ASSOCIATED WITH HUNTINGTONS DISEASE |
| 9MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | April 3, 2024 | TREATMENT OF CHOREA ASSOCIATED WITH HUNTINGTONS DISEASE |
| 12MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | June 24, 2024 | INFORMATION FROM PEDIATRIC STUDIES ADDED TO LABEL |
| 6MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | June 24, 2024 | INFORMATION FROM PEDIATRIC STUDIES ADDED TO LABEL |
| 9MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | June 24, 2024 | INFORMATION FROM PEDIATRIC STUDIES ADDED TO LABEL |
| 12MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | Oct. 3, 2024 | PEDIATRIC EXCLUSIVITY |
| 6MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | Oct. 3, 2024 | PEDIATRIC EXCLUSIVITY |
| 9MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | Oct. 3, 2024 | PEDIATRIC EXCLUSIVITY |
| 12MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | Dec. 24, 2024 | PEDIATRIC EXCLUSIVITY |
| 6MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | Dec. 24, 2024 | PEDIATRIC EXCLUSIVITY |
| 9MG | AUSTEDO | TEVA BRANDED PHARM | N208082 | April 3, 2017 | RX | TABLET | ORAL | Dec. 24, 2024 | PEDIATRIC EXCLUSIVITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Synaptic vesicular amine transporter | Transporter | INHIBITOR | UNKNOWN | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| P341G6W9NB | UNII |
| 4036562 | VANDF |
| C4277781 | UMLSCUI |
| CHEMBL3137326 | ChEMBL_ID |
| 6018 | PUBCHEM_CID |
| DB12161 | DRUGBANK_ID |
| D10701 | KEGG_DRUG |
| 10069 | INN_ID |
| 8707 | IUPHAR_LIGAND_ID |
| 255755 | MMSL |
| 32626 | MMSL |
| d08560 | MMSL |
| 017158 | NDDF |
| 733658007 | SNOMEDCT_US |
| 764363002 | SNOMEDCT_US |
| 1876905 | RXNORM |
| C000609690 | MESH_SUPPLEMENTAL_RECORD_UI |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Austedo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68546-170 | TABLET, COATED | 6 mg | ORAL | NDA | 28 sections |
| Austedo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68546-170 | TABLET, COATED | 6 mg | ORAL | NDA | 28 sections |
| Austedo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68546-170 | TABLET, COATED | 6 mg | ORAL | NDA | 28 sections |
| Austedo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68546-171 | TABLET, COATED | 9 mg | ORAL | NDA | 28 sections |
| Austedo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68546-171 | TABLET, COATED | 9 mg | ORAL | NDA | 28 sections |
| Austedo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68546-171 | TABLET, COATED | 9 mg | ORAL | NDA | 28 sections |
| Austedo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68546-172 | TABLET, COATED | 12 mg | ORAL | NDA | 28 sections |
| Austedo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68546-172 | TABLET, COATED | 12 mg | ORAL | NDA | 28 sections |
| Austedo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68546-172 | TABLET, COATED | 12 mg | ORAL | NDA | 28 sections |
| AUSTEDO XR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68546-470 | TABLET, FILM COATED, EXTENDED RELEASE | 6 mg | ORAL | NDA | 28 sections |
| AUSTEDO XR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68546-471 | TABLET, FILM COATED, EXTENDED RELEASE | 12 mg | ORAL | NDA | 28 sections |
| AUSTEDO XR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68546-472 | TABLET, FILM COATED, EXTENDED RELEASE | 24 mg | ORAL | NDA | 28 sections |