Application 022404

Type: NDA
Sponsor: FORTOVIA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ORAVIG	MICONAZOLE	TABLET;BUCCAL	50MG	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
N022404-001	ORAVIG	MICONAZOLE	50MG	TABLET / BUCCAL		RLD, RS	2010-04-16

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	N022404-001	ORAVIG	50MG	TABLET / BUCCAL	RLD, RS	2010-04-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022404-001	ORAVIG	50MG	TABLET / BUCCAL	RLD, RS	2010-04-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022404-001	ORAVIG	50MG	TABLET / BUCCAL	RLD, RS	2010-04-16	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022404-001	ORAVIG	50MG	TABLET / BUCCAL	RLD, RS	2010-04-16	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 54 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	N022404-001	6916485	2022-09-11	U-1051	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022404-001	7651698	2022-09-11	U-1051			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022404-001	8518442	2022-09-11		Drug product	2013-09-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022404-001	6916485	2022-09-11	U-1051	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022404-001	7651698	2022-09-11	U-1051			`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022404-001	8518442	2022-09-11		Drug product	2013-09-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022404-001	6916485	2022-09-11	U-1051	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022404-001	7651698	2022-09-11	U-1051			`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022404-001	8518442	2022-09-11		Drug product	2013-09-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022404-001	6916485	2022-09-11	U-1051	Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022404-001	7651698	2022-09-11	U-1051			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022404-001	8518442	2022-09-11		Drug product	2013-09-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022404-001	6916485	2022-09-11	U-1051	Drug product		`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022404-001	7651698	2022-09-11	U-1051			`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022404-001	8518442	2022-09-11		Drug product	2013-09-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022404-001	6916485	2022-09-11	U-1051	Drug product		`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022404-001	7651698	2022-09-11	U-1051			`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022404-001	8518442	2022-09-11		Drug product	2013-09-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022404-001	6916485	2022-09-11	U-1051	Drug product		`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022404-001	7651698	2022-09-11	U-1051			`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022404-001	8518442	2022-09-11		Drug product	2013-09-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022404-001	6916485	2022-09-11	U-1051	Drug product		`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022404-001	7651698	2022-09-11	U-1051			`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022404-001	8518442	2022-09-11		Drug product	2013-09-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022404-001	6916485	2022-09-11	U-1051	Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022404-001	7651698	2022-09-11	U-1051			`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022404-001	8518442	2022-09-11		Drug product	2013-09-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022404-001	6916485	2022-09-11	U-1051	Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022404-001	7651698	2022-09-11	U-1051			`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022404-001	8518442	2022-09-11		Drug product	2013-09-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022404-001	6916485	2022-09-11	U-1051	Drug product		`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022404-001	7651698	2022-09-11	U-1051			`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022404-001	8518442	2022-09-11		Drug product	2013-09-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022404-001	6916485	2022-09-11	U-1051	Drug product		`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022404-001	7651698	2022-09-11	U-1051			`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022404-001	8518442	2022-09-11		Drug product	2013-09-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022404-001	6916485	2022-09-11	U-1051	Drug product		`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022404-001	7651698	2022-09-11	U-1051			`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022404-001	8518442	2022-09-11		Drug product	2013-09-17	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N022404-001	6916485	2022-09-11	U-1051	Drug product		`3bdfa0b2c4d7…`

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
Oravig	MICONAZOLE	Galt Pharmaceuticals, LLC	dc2427ff-e566-4b48-b289-9e51c011250a	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022404 application number: NDA022404 ndc (product): 61825-303

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
61825-303	Oravig	Miconazole	Galt Pharmaceuticals, LLC	NDA	Current
89141-250	ORAVIG	miconazole	Midatech Pharma US, Inc.	NDA	Current
89141-250	ORAVIG	miconazole	Midatech Pharma US, Inc.	NDA	Current
89141-250	ORAVIG	miconazole	Midatech Pharma US, Inc.	NDA	Current
89141-250	ORAVIG	miconazole	Midatech Pharma US, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61781	SUPPL	2020-02-05
61777	SUPPL	2020-02-05
17324	SUPPL	2013-03-08
29687	SUPPL	2013-03-06
29686	SUPPL	2011-04-13
38662	SUPPL	2011-04-11
24297	ORIG	2010-12-23
22012	ORIG	2010-12-23
29685	ORIG	2010-05-03
17323	ORIG	2010-05-03