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 9 of 11 · 205 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AZOLEN	MICONAZOLE NITRATE	STRATUS PHARMACEUTICALS INC	3264bd0a-c628-404b-8c09-8586682d054e	2024-10-31	Warnings	Name fallback generic name: MICONAZOLE NITRATE
fungoid tincture	MICONAZOLE NITRATE	Pedinol Pharmacal, Inc.	250d0a66-01d1-4aba-8f24-4cb4ca529fda	2024-10-17	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole 7	MICONAZOLE NITRATE	Major Pharmaceuticals	825ac1c5-470e-4ee1-857d-b205c26fc634	2024-10-07	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Micotrin AP	MICONAZOLE NITRATE	PureTek Corporation	cbe3d495-cdee-2343-e053-2a95a90a5b82	2024-10-01	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Mycozyl AP	MICONAZOLE NITRATE	PureTek Corporation	b3c46a30-7ff2-0dc4-e053-2995a90aa571	2024-10-01	Warnings	Name fallback generic name: MICONAZOLE NITRATE
VAGISTEN-V 7 DAY	MICONAZOLE NITRATE	OPMX LLC	a5bfa501-5ae1-4434-bc31-995d0665b99e	2024-09-04	Warnings	Name fallback generic name: MICONAZOLE NITRATE
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL	MICONAZOLE NITRATE	ASTONEA LABS PRIVATE LIMITED	e66191a6-0c3c-7319-e053-2a95a90aae84	2024-06-25	Warnings	Name fallback generic name: MICONAZOLE NITRATE
THERA Antifungal Body	MICONAZOLE NITRATE	McKesson Medical-Surgical Inc.	31096041-28c9-4b16-bbd1-dbadefd37505	2024-06-14	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Antifungal Body	MICONAZOLE NITRATE	McKesson	4fb9aece-0baa-475e-e054-00144ff8d46c	2024-06-13	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole 7	MICONAZOLE NITRATE	QUALITY CHOICE (Chain Drug Marketing Association)	84bef1d3-e4f8-4769-8f94-5ae91ddc9537	2024-06-06	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Anti-Fungal	MICONAZOLE NITRATE	Universal Distribution Center LLC	8f316b0d-d308-4ae6-82c4-39bb0d1d474e	2024-05-21	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole 7	MICONAZOLE NITRATE	Cardinal Health (Leader) 70000	5081411c-02d0-4f7d-8496-d6adccbe00ae	2024-03-18	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Dermachange Jock	MICONAZOLE NITRATE	Private label Beauty and Wellness	12eef049-76c9-1450-e063-6394a90a00ea	2024-03-05	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole Nitrate	MICONAZOLE NITRATE	A-S Medication Solutions	7a0ef38a-9584-4e67-ba86-c31f86da1ed0	2023-12-11	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole Nitrate	MICONAZOLE NITRATE	A-S Medication Solutions	7d284f6f-a970-49fe-b45a-d5c6c2688bc2	2023-12-11	Warnings	Name fallback generic name: MICONAZOLE NITRATE
miconazole 7	MICONAZOLE NITRATE	H E B	9741b8c0-716a-4c54-9793-387866faf766	2023-11-13	Warnings	Name fallback generic name: MICONAZOLE NITRATE
miconazole 3	MICONAZOLE NITRATE	Rite Aid Corporation	4abee369-e8c5-4971-9545-8c015ff6eaad	2023-11-08	Warnings	Name fallback generic name: MICONAZOLE NITRATE
MacerRx Web	MICONAZOLE NITRATE	Clinical Therapeutic Solutions	c9327f41-10f1-41f3-855b-838c701d6767	2023-11-05	Warnings	Name fallback generic name: MICONAZOLE NITRATE
foster and thrive miconazole 7	MICONAZOLE NITRATE	Strategic Sourcing Services LLC	b06590b5-1dcf-47b7-8e81-5887b1c3893a	2023-11-05	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Evercare Antifungal Treatment Super Absorbent Powder	MICONAZOLE NITRATE	PANEFFORT, LLC	f91910f3-b461-43a4-9120-fda69483fffa	2023-10-26	Warnings	Name fallback generic name: MICONAZOLE NITRATE

Reported adverse events (FAERS/openFDA)#

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