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 11 of 11 · 205 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Good Sense Miconazole 7	MICONAZOLE NITRATE	L Perrigo Company	4902029e-47dd-483b-af03-b1b5936e98ea	2021-01-27	Warnings	Name fallback generic name: MICONAZOLE NITRATE
good sense miconazole 7	MICONAZOLE NITRATE	L. Perrigo Company	090ee644-7f73-4a43-aa5e-bfa74b0d5130	2021-01-06	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Careone miconazole 7	MICONAZOLE NITRATE	American Sales Company	fced0f7f-31b8-4975-836e-3f38c496a450	2021-01-06	Warnings	Name fallback generic name: MICONAZOLE NITRATE
Miconazole Nitrate	MICONAZOLE NITRATE	Actavis Pharma, Inc.	aa9e250b-f317-42cb-b8d2-e85de56f4ef7	2020-10-21	Adverse reactions	Name fallback generic name: MICONAZOLE NITRATE
Micatin	MICONAZOLE NITRATE	WellSpring Pharmaceutical Corporation	96c56ba1-c3a8-48ce-ab58-550959485e3c	2016-04-07	Warnings	Name fallback generic name: MICONAZOLE NITRATE

Reported adverse events (FAERS/openFDA)#

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