Application 020428

Type: NDA
Sponsor: ALMIRALL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AZELEX	AZELAIC ACID	CREAM;TOPICAL	20%	Yes	Yes

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
N020428-001	AZELEX	AZELAIC ACID	20%	CREAM / TOPICAL		RLD, RS	1995-09-13

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	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020428-001	AZELEX	20%	CREAM / TOPICAL	RLD, RS	1995-09-13	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AZELEX	AZELAIC ACID	Almirall, LLC	ebdfcaf7-b5d6-47e1-be87-ccaba4b97e75	2024-03-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020428 application number: NDA020428 ndc (product): 16110-869

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0023-8694	AZELEX	azelaic acid	Allergan, Inc.	NDA	Current
0023-8694	AZELEX	azelaic acid	Allergan, Inc.	NDA	Current
16110-869	AZELEX	azelaic acid	Almirall, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78029	SUPPL	2024-04-02
61523	SUPPL	2020-01-07
57646	ORIG	2019-02-15
12576	SUPPL	2003-06-22
2532	SUPPL	2003-06-22
34647	SUPPL	2003-04-30
41356	SUPPL	2000-06-12
20653	SUPPL	2000-06-12