Application Nr Approved Date Route Status External Links
ANDA202148 2015-09-10 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Acitretin Capsules Are Indicated For The Treatment Of Severe Psoriasis In Adults. Because Of Significant Adverse Effects Associated With Its Use, Acitretin Capsules Should Be Prescribed Only By Those Knowledgeable In The Systemic Use Of Retinoids. In Females Of Reproductive Potential, Acitretin Capsules 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 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 (9 Total)

Name Structure Kind Function Status
1. Edetate Disodium EDETATE DISODIUM Molecular
2. Gelatin GELATIN Unresolved
3. Maltodextrin MALTODEXTRIN Unresolved GRAS-Generally recognized as safe.
4. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
5. Poloxamer 407 POLOXAMER 407 Unresolved
6. Ferric Oxide Red FERRIC OXIDE RED Molecular
7. Potassium Hydroxide POTASSIUM HYDROXIDE Molecular B&N-Buffer & neutralizing agent , MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
8. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
9. Shellac SHELLAC Unresolved

Active Ingredients ( 1 Total)

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

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