Application 020676

Type: NDA
Sponsor: COMBE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VAGISTAT-1	TIOCONAZOLE	OINTMENT;VAGINAL	6.5%	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
N020676-001	VAGISTAT-1	TIOCONAZOLE	6.5%	OINTMENT / VAGINAL		RLD, RS	1997-02-11

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	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020676-001	VAGISTAT-1	6.5%	OINTMENT / VAGINAL	RLD, RS	1997-02-11	`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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TIOCONAZOLE 1	TIOCONAZOLE	Amazon.com Services LLC	cea5dd1c-a59a-4877-8476-85ed6cc4e221	2026-07-29	Warnings	Name fallback generic name: TIOCONAZOLE
TIOCONAZOLE 1	TIOCONAZOLE	Safeway	5b7d477e-835b-4557-9a05-c5959dbc803e	2026-05-01	Warnings	Name fallback generic name: TIOCONAZOLE
Tioconazole 1	TIOCONAZOLE	H E B	8bd3f5e8-5a8f-4d6a-b257-c315eec66318	2026-04-04	Warnings	Name fallback generic name: TIOCONAZOLE
tioconazole 1	TIOCONAZOLE	Meijer Distribution Inc	7f0b0a4a-f8b5-4d86-afad-fe7e7eee2a31	2026-03-26	Warnings	Name fallback generic name: TIOCONAZOLE
Equate tioconazole 1 day	TIOCONAZOLE	Wal-Mart Stores Inc	6b3ee10a-d945-41f4-bbb5-ff2e2fdcd22c	2025-08-11	Warnings	Name fallback generic name: TIOCONAZOLE
Up and up tioconazole 1	TIOCONAZOLE	Target Corporation	4086b77c-b08d-4f53-a4ab-4f5af814a605	2025-07-16	Warnings	Name fallback generic name: TIOCONAZOLE
signature care tioconazole 1	TIOCONAZOLE	Safeway	22ac4774-87b4-437f-8520-e4a4ed6e1c55	2025-03-20	Warnings	Name fallback generic name: TIOCONAZOLE
Leader Tioconazole 1	TIOCONAZOLE	Cardinal Health 110, LLC. dba Leader	6db31d83-acd7-4e4e-8f98-fe46102a6832	2025-02-19	Warnings	Name fallback generic name: TIOCONAZOLE
CareOne Tioconazole 1	TIOCONAZOLE	American Sales Company	78139c20-6258-4da6-abd3-9ba5e5899fd9	2024-12-18	Warnings	Name fallback generic name: TIOCONAZOLE
Tioconazole 1	TIOCONAZOLE	Walgreen Company	c05a4413-8a5f-4b91-9c22-b1db785e8e9e	2024-12-18	Warnings	Name fallback generic name: TIOCONAZOLE
basic care tioconazole	TIOCONAZOLE	Amazon.com Services LLC	0484dbe9-37a6-4b98-b29a-3c006205c94d	2024-12-18	Warnings	Name fallback generic name: TIOCONAZOLE
tioconazole 1	TIOCONAZOLE	CVS Pharmacy	49ef74a9-9850-4427-8658-ee4dd9050ae0	2024-08-09	Warnings	Name fallback generic name: TIOCONAZOLE
Topcare Tioconazole 1	TIOCONAZOLE	Topco Associates LLC	fce06160-2098-4ac1-9cc3-a584d4f5a51d	2024-08-08	Warnings	Name fallback generic name: TIOCONAZOLE
VAGISTAT	TIOCONAZOLE	Combe Incorporated	da8eaa33-4195-487f-a234-472dd1036225	2024-06-22	Warnings	Name fallback generic name: TIOCONAZOLE
good sense tioconazole 1	TIOCONAZOLE	L. Perrigo Company	d39ac447-6e1d-4b77-90c1-a9a653661f42	2023-12-19	Warnings	Name fallback generic name: TIOCONAZOLE
foster and thrive tioconazole	TIOCONAZOLE	Strategic Sourcing Services LLC	daa1027d-de49-41dc-9d4d-9bbdd7b359c8	2023-10-25	Warnings	Name fallback generic name: TIOCONAZOLE
Equaline Tioconazole 1	TIOCONAZOLE	United Natural Foods, Inc. dba UNFI	e5bfbe25-9f90-41ff-b15a-9f9389de7052	2023-07-24	Warnings	Name fallback generic name: TIOCONAZOLE
dg health tioconazole 1	TIOCONAZOLE	Dolgencorp, LLC	39bada3c-510e-47ae-a125-30e41e483382	2021-05-11	Warnings	Name fallback generic name: TIOCONAZOLE
MONISTAT TIOCONAZOLE 1	TIOCONAZOLE	Insight Pharmaceuticals LLC	587e42b4-cbdc-4a03-afae-f9e5e6605937	2019-03-19	Warnings	Name fallback generic name: TIOCONAZOLE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
13186	SUPPL	2014-08-13
3060	SUPPL	2009-11-10
41538	ORIG	2003-08-08
35125	SUPPL	2003-04-30