Application 019729

Type: NDA
Sponsor: ASTELLAS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CYCLOCORT	AMCINONIDE	LOTION;TOPICAL	0.1%	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
N019729-001	CYCLOCORT	AMCINONIDE	0.1%	LOTION / TOPICAL		RLD	1988-06-13

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	N019729-001	CYCLOCORT	0.1%	LOTION / TOPICAL	RLD	1988-06-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019729-001	CYCLOCORT	0.1%	LOTION / TOPICAL	RLD	1988-06-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N019729-001	CYCLOCORT	0.1%	LOTION / TOPICAL	RLD	1988-06-13	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N019729-001	CYCLOCORT	0.1%	LOTION / TOPICAL	RLD	1988-06-13	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Amcinonide	AMCINONIDE	INA PHARMACEUTICS INC.	e7dc754e-eeff-4c30-a52a-629c72ad2415	2025-07-07	Adverse reactions	Name fallback generic name: AMCINONIDE
Amcinonide	AMCINONIDE	Sun Pharmaceutical Industries, Inc.	ac5c3e79-52f7-434e-92ae-24bd32b45edc	2025-04-03	Adverse reactions	Name fallback generic name: AMCINONIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
40985	ORIG	2001-05-25