tazarotene Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| arotinoid derivatives | 2571 | 118292-40-3 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
a topical acetylenic retinoid; a topical kerytolytic
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| Vd (Volume of distribution) | 3.55 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 37.20 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 6.22 hours | Lombardo F, Berellini G, Obach RS |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| June 13, 1997 | FDA | ALLERGAN |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | D05AX05 | DERMATOLOGICALS ANTIPSORIATICS ANTIPSORIATICS FOR TOPICAL USE Other antipsoriatics for topical use |
| ATC | D05AX55 | DERMATOLOGICALS ANTIPSORIATICS ANTIPSORIATICS FOR TOPICAL USE Other antipsoriatics for topical use |
| FDA CS | M0018962 | Retinoids |
| FDA EPC | N0000175607 | Retinoid |
| MeSH PA | D003879 | Dermatologic Agents |
| MeSH PA | D007641 | Keratolytic Agents |
| MeSH PA | D009676 | Noxae |
| MeSH PA | D013723 | Teratogens |
| CHEBI has role | CHEBI:50176 | desquamating agent |
| CHEBI has role | CHEBI:50266 | prodrugs |
| CHEBI has role | CHEBI:50905 | teratogen |
Drug Use (View source of the data)
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Psoriasis | indication | 9014002 | DOID:8893 |
| Acne vulgaris | indication | 88616000 | |
| Facial Hyperpigmentation | indication | ||
| Benign Facial Lentigine | indication | ||
| Facial Fine Wrinkling | indication | ||
| Facial Hypopigmentation | indication | ||
| Sunburn | contraindication | 23346002 | |
| Photosensitivity | contraindication | 90128006 | |
| Pregnancy, function | contraindication | 289908002 |
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 2.17 | Basic |
Orange Book patent data (new drug applications)
None
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 0.01%;0.045% | DUOBRII | BAUSCH | N209354 | April 25, 2019 | RX | LOTION | TOPICAL | April 25, 2022 | NEW PRODUCT |
| 0.045% | ARAZLO | BAUSCH | N211882 | Dec. 18, 2019 | RX | LOTION | TOPICAL | Dec. 18, 2022 | NEW PRODUCT |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Retinoic acid receptor beta | Nuclear hormone receptor | AGONIST | EC50 | 9.10 | CHEMBL | CHEMBL | |||
| Retinoic acid receptor alpha | Nuclear hormone receptor | AGONIST | EC50 | 7.20 | CHEMBL | CHEMBL | |||
| Retinoic acid receptor gamma | Nuclear hormone receptor | AGONIST | EC50 | 7.40 | CHEMBL | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4021045 | VUID |
| N0000148509 | NUI |
| D01132 | KEGG_DRUG |
| 4021045 | VANDF |
| C0253908 | UMLSCUI |
| CHEBI:32184 | CHEBI |
| CHEMBL1657 | ChEMBL_ID |
| 5381 | PUBCHEM_CID |
| C086827 | MESH_SUPPLEMENTAL_RECORD_UI |
| 7328 | INN_ID |
| DB00799 | DRUGBANK_ID |
| 81BDR9Y8PS | UNII |
| 6952 | IUPHAR_LIGAND_ID |
| 1293452 | RXNORM |
| 10196 | MMSL |
| 190198 | MMSL |
| 255259 | MMSL |
| 5542 | MMSL |
| 006668 | NDDF |
| 108906007 | SNOMEDCT_US |
| 386935009 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| TAZORAC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0023-0042 | GEL | 1 mg | CUTANEOUS | NDA | 29 sections |
| TAZORAC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0023-8335 | GEL | 0.50 mg | CUTANEOUS | NDA | 29 sections |
| TAZORAC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0023-9155 | CREAM | 0.50 mg | CUTANEOUS | NDA | 26 sections |
| TAZORAC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0023-9156 | CREAM | 1 mg | CUTANEOUS | NDA | 26 sections |
| TAZAROTENE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0168-0454 | CREAM | 1 mg | TOPICAL | ANDA | 26 sections |
| Tazarotene Cream | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0168-0455 | CREAM | 1 mg | TOPICAL | ANDA | 25 sections |
| Duobrii | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0187-0653 | LOTION | 0.45 mg | TOPICAL | NDA | 25 sections |
| Arazlo | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0187-2098 | LOTION | 0.45 mg | TOPICAL | NDA | 24 sections |
| Tazarotene | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0713-0670 | CREAM | 1 mg | TOPICAL | ANDA | 27 sections |
| Tazarotene | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0713-0764 | CREAM | 1 mg | TOPICAL | ANDA | 27 sections |
| Tazorac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16110-042 | GEL | 1 mg | CUTANEOUS | NDA | 29 sections |
| Tazorac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16110-833 | GEL | 0.50 mg | CUTANEOUS | NDA | 29 sections |
| TAZORAC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16110-915 | CREAM | 0.05 mg | CUTANEOUS | NDA | 29 sections |
| TAZORAC | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16110-916 | CREAM | 0.10 mg | CUTANEOUS | NDA | 29 sections |
| Tazarotene | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51672-1373 | CREAM | 1 mg | TOPICAL | ANDA | 27 sections |
| Tazarotene | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51672-1374 | CREAM | 1 mg | TOPICAL | ANDA | 27 sections |
| FABIOR | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51862-295 | AEROSOL, FOAM | 1 mg | TOPICAL | NDA | 27 sections |
| Tazorac | HUMAN PRESCRIPTION DRUG LABEL | 1 | 54868-4456 | GEL | 1 mg | ORAL | NDA | 14 sections |
| Tazarotene | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60758-556 | CREAM | 0.50 mg | TOPICAL | NDA | 26 sections |
| Tazarotene | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60758-561 | CREAM | 1 mg | TOPICAL | NDA | 26 sections |
| tazarotene | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68308-685 | AEROSOL, FOAM | 1 mg | TOPICAL | NDA authorized generic | 29 sections |
| CLINDAMYCIN 1% / NIACINULLMIDE 2% / TAZAROTENE 0.05% | HUMAN PRESCRIPTION DRUG LABEL | 3 | 72934-1050 | GEL | 0.05 g | TOPICAL | unapproved drug other | 4 sections |
| NIACINULLMIDE 4% / TAZAROTENE 0.1% | HUMAN PRESCRIPTION DRUG LABEL | 2 | 72934-1161 | GEL | 0.10 g | TOPICAL | unapproved drug other | 4 sections |
| HYALURONIC ACID SODIUM SALT 0.5% / TAZAROTENE 0.05% | HUMAN PRESCRIPTION DRUG LABEL | 2 | 72934-2093 | CREAM | 0.05 g | TOPICAL | unapproved drug other | 4 sections |
| HYALURONIC ACID SODIUM SALT 0.5% / TAZAROTENE 0.1% | HUMAN PRESCRIPTION DRUG LABEL | 2 | 72934-2094 | CREAM | 0.10 g | TOPICAL | unapproved drug other | 4 sections |
| NIACINULLMIDE 4% / TAZAROTENE 0.05% | HUMAN PRESCRIPTION DRUG LABEL | 2 | 72934-2160 | CREAM | 0.05 g | TOPICAL | unapproved drug other | 4 sections |
| NIACINULLMIDE 4% / TAZAROTENE 0.1% | HUMAN PRESCRIPTION DRUG LABEL | 2 | 72934-2161 | CREAM | 0.10 g | TOPICAL | unapproved drug other | 4 sections |
| 011312 NIACINULLMIDE 4% / TAZAROTENE 0.05% | HUMAN PRESCRIPTION DRUG LABEL | 2 | 72934-2208 | CREAM | 0.05 g | TOPICAL | unapproved drug other | 4 sections |