Application 020941

Type: NDA
Sponsor: GLAXOSMITHKLINE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ABREVA	DOCOSANOL	CREAM;TOPICAL	10%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N020941-001	ABREVA	DOCOSANOL	10%	CREAM / TOPICAL		RLD, RS	2000-07-25

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 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020941-001	ABREVA	10%	CREAM / TOPICAL	RLD, RS	2000-07-25	`cb3db0bc1861…`

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
ABREVA	DOCOSANOL	Haleon US Holdings LLC	c39b38a7-dcdd-4c32-8f35-b565c4d3cec6	2024-06-20	Warnings	Exact identifier application applno (NDA): 020941 application number: NDA020941 ndc (product): 0135-0200

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0135-0200	ABREVA	docosanol	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
0135-0200	ABREVA	docosanol	GlaxoSmithKline Consumer Healthcare Holdings (US) LLC	NDA	Current
50090-3476	ABREVA	docosanol	A-S Medication Solutions	NDA	Current
50090-3476	ABREVA	docosanol	A-S Medication Solutions	NDA	Current
50090-3476	ABREVA	docosanol	A-S Medication Solutions	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85769	SUPPL	2026-04-27
85692	SUPPL	2026-04-20
46952	SUPPL	2017-01-24
46874	SUPPL	2017-01-18
13789	SUPPL	2015-02-17
26258	SUPPL	2015-02-02
3814	SUPPL	2008-02-14
35686	SUPPL	2007-05-29
3813	SUPPL	2007-05-29
21293	ORIG	2001-08-21
26257	ORIG	2000-07-25
13788	ORIG	2000-07-25