Product manufactured by Impax Generics

Application Nr Approved Date Route Status External Links
ANDA202552 2015-12-23 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Acitretin Capsules, Usp Are Indicated For The Treatment Of Severe Psoriasis In Adults. Because Of Significant Adverse Effects Associated With Its Use, Acitretin Capsules, Usp Should Be Prescribed Only By Those Knowledgeable In The Systemic Use Of Retinoids. In Females Of Reproductive Potential, Acitretin Capsules, Usp Should Be Reserved For Non-Pregnant Patients Who Are Unresponsive To Other Therapies Or Whose Clinical Condition Contraindicates The Use Of Other Treatments (see Boxed Contraindications And Warnings — Acitretin Capsules, Usp Can Cause Severe Birth Defects). Most Patients Experience Relapse Of Psoriasis After Discontinuing Therapy. Subsequent Courses, When Clinically Indicated, Have Produced Efficacy Results Similar To The Initial Course Of Therapy.

All Formulated Excipients (5 Total)

Name Structure Kind Function Status
1. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
2. Maltodextrin MALTODEXTRIN Unresolved GRAS-Generally recognized as safe.
3. Sodium Ascorbate SODIUM ASCORBATE Molecular PRES-Chemical preservative GRAS-Generally recognized as safe.
4. Gelatin GELATIN Unresolved
5. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Acitretin ACITRETIN ZINC3798734