Active substance
Diflorasone diacetate
- US FDA 13
- Safety 4
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| DIFLORASONE DIACETATE | 0.05% | ointment · topical | AVONDALE PHARMS | Prescription | 27 Apr 1999 |
| DIFLORASONE DIACETATE | 0.05% | ointment · topical | SUN PHARMA CANADA | Prescription | 14 May 1999 |
| DIFLORASONE DIACETATE | 0.05% | cream · topical | SUN PHARMA CANADA | Prescription | 24 Apr 2000 |
| DIFLORASONE DIACETATE | 0.05% | ointment · topical | RISING | Prescription | 27 Feb 2017 |
| DIFLORASONE DIACETATE | 0.05% | ointment · topical | THE J MOLNER | Prescription | 12 Jun 2018 |
| FLORONE | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | cream · topical | PFIZER | Discontinued | 14 Sep 1977 |
| PSORCON E | 0.05% | ointment · topical | PFIZER | Discontinued | 1 Mar 1978 |
| FLORONE E | 0.05% | cream · topical | PFIZER | Discontinued | 28 Aug 1985 |
| PSORCON | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ointment · topical | PFIZER | Discontinued | 28 Aug 1985 |
| PSORCON | 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | cream · topical | TARO PHARMS NORTH | Discontinued | 20 Nov 1992 |
| DIFLORASONE DIACETATE | 0.05% | cream · topical | AVONDALE PHARMS | Discontinued | 30 Mar 1998 |
| DIFLORASONE DIACETATE | 0.05% | cream · topical | ANI PHARMS | Discontinued | 20 Dec 2002 |
| DIFLORASONE DIACETATE | 0.05% | ointment · topical | SCIEGEN PHARMS | Discontinued | 24 Jul 2015 |
Safety signals and safety-related labeling changes
- US FDA 25 Oct 2017 FLORONE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 25 Oct 2017 FLORONE E — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 25 Oct 2017 PSORCON — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 25 Oct 2017 PSORCON E — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.