Application 020205

Type: NDA
Sponsor: TARO PHARMS NORTH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PSORCON	DIFLORASONE DIACETATE	CREAM;TOPICAL	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020205-001	PSORCON	DIFLORASONE DIACETATE	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1992-11-20

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N020205-001	PSORCON	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1992-11-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020205-001	PSORCON	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1992-11-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020205-001	PSORCON	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1992-11-20	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020205-001	PSORCON	0.05% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL	RLD	1992-11-20	`a50c72e98297…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diflorasone Diacetate	DIFLORASONE DIACETATE	Sun Pharmaceutical Industries, Inc.	b20c9420-8fb4-4a49-93f0-c0e4074d6d71	2025-09-22	Adverse reactions	Name fallback generic name: DIFLORASONE DIACETATE
Diflorasone Diacetate	DIFLORASONE DIACETATE	Sun Pharmaceutical Industries, Inc.	b304dfca-e840-4c03-8217-73aaa5360277	2025-07-03	Adverse reactions	Name fallback generic name: DIFLORASONE DIACETATE
psorcon	DIFLORASONE DIACETATE	Sun Pharmaceutical Industries, Inc.	de40cc65-f955-423f-9cbd-bc2245c4f982	2025-07-02	Adverse reactions	Name fallback brand name: psorcon generic name: DIFLORASONE DIACETATE
Diflorasone Diacetate	DIFLORASONE DIACETATE	Rising Pharma Holdings, Inc.	23eb27a4-157f-4eb5-a390-37586710808f	2023-05-02	Adverse reactions	Name fallback generic name: DIFLORASONE DIACETATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.