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 7 of 11 · 205 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SUNMARK MICONAZOLE NITRATE antifungal	MICONAZOLE NITRATE	Strategic Sourcing Services LLC	7c15d95a-5b89-4789-8c91-3f61d7ec7707	2025-07-30	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Antifungal	MICONAZOLE NITRATE	Advanced Rx LLC	e13eb653-3916-444a-ae86-1738c0308b79	2025-07-28	Warnings	Name fallback generic name: MICONAZOLE NITRATE
FifthPulse Miconazole Nitrate Cream 1oz	MICONAZOLE NITRATE	Front Pharmaceutical PLC	3a37a3a8-9d05-926c-e063-6294a90a9ed8	2025-07-18	Warnings	Name fallback generic name: MICONAZOLE NITRATE
FifthPulse Miconazole Nitrate Cream 4oz	MICONAZOLE NITRATE	Front Pharmaceutical PLC	3a382b79-dde9-dde0-e063-6294a90a53bb	2025-07-18	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole 3	MICONAZOLE NITRATE	TARGET Corporation	12a2e441-4fdf-4c5e-b033-ba05ef12fc2f	2025-07-18	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole Nitrate	MICONAZOLE NITRATE	STRATEGIC SOURCING SERVICES LLC	966a1000-3b08-4f2c-a9f8-568f2524b717	2025-07-15	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Conazol	MICONAZOLE NITRATE	Laboratorios Liomont, S.A. de C.V.	84780538-8618-5750-e053-2a91aa0a6054	2025-07-07	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Lagicam antifungal	MICONAZOLE NITRATE	Genomma Lab USA, Inc.	85043273-7411-48f5-8ad4-3f00e03cafa3	2025-07-02	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole Nitrate	MICONAZOLE NITRATE	Sun Pharmaceutical Industries, Inc.	eaca3e39-6ea0-4d7e-803c-db22024ad9f9	2025-07-01	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole	MICONAZOLE NITRATE	Chain Drug Consortium, LLC	246be926-79ea-4e0c-a3ef-2aa7fc3a52bf	2025-06-30	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Good Neighbor Pharmacy Miconazole 3	MICONAZOLE NITRATE	Amerisource Bergen	5b87b837-3f52-40ca-b2b6-9c1f1262d90d	2025-06-23	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Fungus Master	MICONAZOLE NITRATE	Clinical Resolution Laboratory, Inc.	36eb334e-246b-249f-e063-6294a90ab811	2025-06-06	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Fungazol Athlete Foot	MICONAZOLE NITRATE	Rida LLC	ce60e1ec-a69b-4b98-a2b2-105e9cd37bc7	2025-05-28	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Good Sense Miconazole 3	MICONAZOLE NITRATE	L. Perrigo Company	9aeac709-001b-4617-8046-186264847ec8	2025-05-15	Warnings	Name fallback generic name: MICONAZOLE NITRATE
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL	MICONAZOLE NITRATE	Cardinal Health 110 dba LEADER	34f4c733-2eb2-0db0-e063-6394a90a6431	2025-05-13	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole 3	MICONAZOLE NITRATE	CVS Pharmacy	9f506f59-e435-465d-90c7-9b0edc44160d	2025-04-24	Warnings	Name fallback generic name: MICONAZOLE NITRATE
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL	MICONAZOLE NITRATE	GERI-GENTLE CORPORATION	e6734616-c16b-430c-e053-2a95a90a18f8	2025-04-21	Warnings	Name fallback generic name: MICONAZOLE NITRATE
vagisil brand vagistat	MICONAZOLE NITRATE	Combe Incorporated	833a5e4d-0591-4300-8f9c-fd00ffaf6041	2025-04-15	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Folliculitis Treatment Cream	MICONAZOLE NITRATE	TAGRID LLC	32396be0-f74a-5483-e063-6294a90ab3ae	2025-04-07	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Tagrid Jock Itch Miconazole Nitrate 2%	MICONAZOLE NITRATE	TAGRID LLC	31abdc68-5027-15e7-e063-6394a90ac4e6	2025-03-31	Warnings	Name fallback generic name: MICONAZOLE NITRATE

Reported adverse events (FAERS/openFDA)#

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