Application 021026

Type: NDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VUSION	MICONAZOLE NITRATE; PETROLATUM, WHITE; ZINC OXIDE	OINTMENT;TOPICAL	0.25%;81.35%;15%	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
N021026-001	VUSION	MICONAZOLE NITRATE; WHITE PETROLATUM; ZINC OXIDE	0.25%;81.35%;15%	OINTMENT / TOPICAL		RLD, RS	2006-02-16

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021026-001	8147852	2028-03-30	U-1426		2013-09-11

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	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021026-001	VUSION	0.25%;81.35%;15%	OINTMENT / TOPICAL	RLD, RS	2006-02-16	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021026-001	8147852	2028-03-30	U-1426	2013-09-11	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VUSION	MICONAZOLE NITRATE, ZINC OXIDE, WHITE PETROLATUM	Mylan Pharmaceuticals Inc.	b44b452d-3630-4cb5-8ed1-1f8edac4690c	2018-08-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021026 application number: NDA021026 ndc (product): 0378-9730
VUSION	MICONAZOLE NITRATE, ZINC OXIDE, WHITE PETROLATUM	Mylan Pharmaceuticals Inc.	b026bc7d-3a18-41e8-88c4-1e063cd2f42c	2018-08-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021026 application number: NDA021026 ndc (product): 0378-8222

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-8222	VUSION	miconazole nitrate, zinc oxide, white petrolatum	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-8222	VUSION	miconazole nitrate, zinc oxide, white petrolatum	Mylan Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
0378-9730	VUSION	miconazole nitrate, zinc oxide, white petrolatum	Mylan Pharmaceuticals Inc.	NDA	Current
0378-9730	VUSION	miconazole nitrate, zinc oxide, white petrolatum	Mylan Pharmaceuticals Inc.	NDA	Current
0378-9730	VUSION	miconazole nitrate, zinc oxide, white petrolatum	Mylan Pharmaceuticals Inc.	NDA	Current
40076-002	VUSION	miconazole nitrate, zinc oxide, white petrolatum	Prestium Pharma, Inc.	NDA	Current
40076-002	VUSION	miconazole nitrate, zinc oxide, white petrolatum	Prestium Pharma, Inc.	NDA	Current
40076-002	VUSION	miconazole nitrate, zinc oxide, white petrolatum	Prestium Pharma, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
55370	SUPPL	2018-08-30
35925	SUPPL	2010-04-04
4086	SUPPL	2010-04-02
41887	ORIG	2009-11-05
35924	SUPPL	2007-10-10
4085	SUPPL	2007-10-04
4084	ORIG	2006-03-01
35923	ORIG	2006-02-22