Application 020827

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	CREAM;VAGINAL	4%	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N020827-001	MONISTAT 3	MICONAZOLE NITRATE	4%	CREAM / VAGINAL		RLD, RS	1998-03-30

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020827-001	MONISTAT 3	4%	CREAM / VAGINAL	RLD, RS	1998-03-30	`cb3db0bc1861…`

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
Monistat 3 3 Day	MICONAZOLE NITRATE	Insight Pharmaceuticals LLC	f38c7e1d-2439-4b3b-8be8-60b2d8e61ce5	2025-10-23	Warnings	Exact identifier application applno (NDA): 020827 application number: NDA020827 ndc (product): 63736-015

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63736-015	Monistat 3	Miconazole Nitrate	Insight Pharmaceuticals LLC	NDA	Current
63736-015	Monistat 3	Miconazole Nitrate	Insight Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
68915	SUPPL	2021-10-08
61723	SUPPL	2020-01-29
61722	SUPPL	2020-01-29
49514	SUPPL	2017-08-22
25936	SUPPL	2009-11-10
25935	SUPPL	2008-09-09
3440	SUPPL	2002-08-07
41724	ORIG	1998-03-30
25934	ORIG	1998-03-30
13502	ORIG	1998-03-30