Application 021758

Type: NDA
Sponsor: MEDICIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VANOS	FLUOCINONIDE	CREAM;TOPICAL	0.1%	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
N021758-001	VANOS	FLUOCINONIDE	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N021758-001	AB

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021758-001	VANOS	0.1%	CREAM / TOPICAL	AB	RLD, RS	2005-02-11	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021758-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021758-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021758-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021758-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021758-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021758-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021758-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021758-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021758-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021758-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021758-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021758-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021758-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021758-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021758-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021758-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021758-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021758-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021758-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021758-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021758-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021758-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021758-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021758-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021758-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021758-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021758-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021758-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021758-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021758-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021758-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021758-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021758-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021758-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021758-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021758-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021758-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021758-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021758-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021758-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 75 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021758-001	7794738	2022-09-11	U-1084			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021758-001	7220424	2023-01-07	U-861			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021758-001	8232264	2023-03-09		Drug product	2012-08-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021758-001	7794738	2022-09-11	U-1084			`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021758-001	7220424	2023-01-07	U-861			`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021758-001	8232264	2023-03-09		Drug product	2012-08-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021758-001	7794738	2022-09-11	U-1084			`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021758-001	7220424	2023-01-07	U-861			`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021758-001	8232264	2023-03-09		Drug product	2012-08-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021758-001	6765001	2021-12-21		Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021758-001	7794738	2022-09-11	U-1084			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021758-001	7220424	2023-01-07	U-861			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021758-001	8232264	2023-03-09		Drug product	2012-08-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021758-001	7794738	2022-09-11	U-1084			`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021758-001	7220424	2023-01-07	U-861			`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021758-001	8232264	2023-03-09		Drug product	2012-08-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021758-001	6765001	2021-12-21		Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021758-001	7794738	2022-09-11	U-1084			`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021758-001	7220424	2023-01-07	U-861			`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021758-001	8232264	2023-03-09		Drug product	2012-08-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021758-001	6765001	2021-12-21		Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021758-001	7794738	2022-09-11	U-1084			`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021758-001	7220424	2023-01-07	U-861			`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021758-001	8232264	2023-03-09		Drug product	2012-08-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021758-001	6765001	2021-12-21		Drug product		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021758-001	7794738	2022-09-11	U-1084			`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021758-001	7220424	2023-01-07	U-861			`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021758-001	8232264	2023-03-09		Drug product	2012-08-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021758-001	6765001	2021-12-21		Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021758-001	7794738	2022-09-11	U-1084			`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021758-001	7220424	2023-01-07	U-861			`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021758-001	8232264	2023-03-09		Drug product	2012-08-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021758-001	6765001	2021-12-21		Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021758-001	7794738	2022-09-11	U-1084			`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021758-001	7220424	2023-01-07	U-861			`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021758-001	8232264	2023-03-09		Drug product	2012-08-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021758-001	6765001	2021-12-21		Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021758-001	7794738	2022-09-11	U-1084			`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021758-001	7220424	2023-01-07	U-861			`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021758-001	8232264	2023-03-09		Drug product	2012-08-02	`3f01610625f2…`

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
Vanos	FLUOCINONIDE	Bausch Health US, LLC	95cb19a0-4b71-4c66-92bd-901cfd223301	2024-02-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021758 application number: NDA021758 ndc (product): 99207-525

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
68682-992	Fluocinonide	fluocinonide	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
68682-992	Fluocinonide	fluocinonide	Oceanside Pharmaceuticals	NDA AUTHORIZED GENERIC	Current
99207-525	Vanos	fluocinonide	Bausch Health US, LLC	NDA	Current
99207-525	Vanos	fluocinonide	Bausch Health US LLC	NDA	Current
99207-525	Vanos	fluocinonide	Valeant Pharmaceuticals North America LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
37593	SUPPL	2012-03-20
28535	SUPPL	2012-03-19
16320	SUPPL	2011-11-16
6131	SUPPL	2011-11-16
28534	SUPPL	2011-01-05
16319	SUPPL	2010-12-30
28533	SUPPL	2010-03-10
37592	SUPPL	2010-03-09
42301	ORIG	2007-07-18
28532	SUPPL	2006-12-28
37591	SUPPL	2006-12-26
37590	SUPPL	2006-03-03
6130	SUPPL	2006-03-03
28531	SUPPL	2005-11-30
16318	ORIG	2005-02-17
6129	ORIG	2005-02-17