Application 018888

Type: NDA
Sponsor: MEDTECH PRODUCTS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MONISTAT 3	MICONAZOLE NITRATE	SUPPOSITORY;VAGINAL	200MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N018888-001	MONISTAT 3	MICONAZOLE NITRATE	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N018888-001	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 · 43 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
2026-09-14 22:38:34	2026-08	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018888-001	MONISTAT 3	200MG	SUPPOSITORY / VAGINAL	AB	RLD, RS	1984-08-15	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N018888-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N018888-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N018888-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N018888-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N018888-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N018888-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N018888-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N018888-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N018888-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N018888-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N018888-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N018888-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N018888-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N018888-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N018888-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N018888-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N018888-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N018888-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N018888-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N018888-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N018888-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N018888-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N018888-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N018888-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N018888-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N018888-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N018888-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N018888-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N018888-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N018888-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N018888-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N018888-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N018888-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N018888-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N018888-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N018888-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N018888-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N018888-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N018888-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N018888-001	AB	1	`f41ea6bd6efb…`

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 4 of 11 · 205 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Miconazole 1 Walgreens	MICONAZOLE NITRATE	WALGREEN COMPANY	1fe7b02a-f60b-4572-b4e8-35bda290b176	2026-01-23	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole Nitrate	MICONAZOLE NITRATE	AvKARE	1a26534d-eeb8-8d17-e063-6294a90a70c7	2026-01-19	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Lotrimin Antifungal	MICONAZOLE NITRATE	Bayer HealthCare LLC.	cebd222c-074f-443c-bd37-612114b27bbd	2026-01-16	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Lotrimin AF Jock Itch	MICONAZOLE NITRATE	Bayer HealthCare LLC.	1300d84f-d7ff-ec57-e063-6294a90ae0de	2026-01-16	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Antifungal Ringworm Treatment	MICONAZOLE NITRATE	Rida LLC	eb953281-cf86-44cf-a3d1-37b8d344a6bc	2026-01-15	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Desenex	MICONAZOLE NITRATE	Crown Laboratories	09964187-12f1-bbe6-e063-6394a90acba0	2026-01-12	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Zeasorb Jock Itch	MICONAZOLE NITRATE	Crown Laboratories	09d088ef-aab3-5565-e063-6394a90af263	2026-01-12	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Zeasorb Athletes Foot	MICONAZOLE NITRATE	Crown Laboratories	09bb313e-90cb-5629-e063-6294a90ac268	2026-01-12	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Desenex Antifungal Foot Cream	MICONAZOLE NITRATE	Crown Laboratories, Inc.	311abb56-e176-0510-e063-6294a90a97f5	2026-01-12	Warnings	Name fallback generic name: MICONAZOLE NITRATE
miconazole nitrate	MICONAZOLE NITRATE	AvPAK	eaf016f6-b631-af00-e053-2a95a90adc7b	2026-01-09	Warnings	Name fallback generic name: MICONAZOLE NITRATE
White Tetterine	MICONAZOLE NITRATE	S.S.S. Company	861895df-c989-4afd-bb31-c87c644139ef	2026-01-08	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Green Tetterine	MICONAZOLE NITRATE	S.S.S. Company	4de96ed4-7506-4acd-8e8d-ea74bfd18e4a	2026-01-08	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Antifungal Powder	MICONAZOLE NITRATE	LEADER/ Cardinal Health 110, Inc.	1fcf072b-cf12-967a-e063-6294a90acfc7	2025-12-31	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Lasolex AG	MICONAZOLE NITRATE	Puretek Corporation	4411142f-a8ec-c8c2-e063-6394a90aa25c	2025-12-31	Warnings	Name fallback generic name: MICONAZOLE NITRATE
foster and thrive miconazole 3	MICONAZOLE NITRATE	Strategic Sourcing Services LLC	4c536e07-5e88-4bdd-a5b2-10226d5486ed	2025-12-16	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Lotrimin AF Jock Itch	MICONAZOLE NITRATE	Bayer Healthcare LLC.	0c53cf0f-767e-a422-e063-6394a90ab764	2025-12-04	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Lotrimin AF Deodorant	MICONAZOLE NITRATE	Bayer HealthCare LLC.	0bee54eb-df2f-15fe-e063-6294a90a2fd2	2025-12-04	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Lotrimin AF	MICONAZOLE NITRATE	Bayer Healthcare LLC.	163996c6-af54-21ac-e063-6394a90ac05c	2025-12-04	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole Nitrate	MICONAZOLE NITRATE	A-S Medication Solutions	23ca78c0-16a9-455c-99a7-b9a9a3affa60	2025-12-03	Warnings	Name fallback generic name: MICONAZOLE NITRATE
CAREALL Miconazole Nitrate	MICONAZOLE NITRATE	New World Imports, Inc	bed775be-8bcb-44c2-9b9f-8bb25b4b2453	2025-12-01	Warnings	Name fallback generic name: MICONAZOLE NITRATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.