Application 075329

Type: ANDA
Sponsor: PERRIGO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MICONAZOLE NITRATE COMBINATION PACK	MICONAZOLE NITRATE	CREAM, SUPPOSITORY;TOPICAL, VAGINAL	2%,200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A075329-001	MICONAZOLE NITRATE COMBINATION PACK	MICONAZOLE NITRATE	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL			1999-04-20

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A075329-001	MICONAZOLE NITRATE COMBINATION PACK	2%,200MG	CREAM, SUPPOSITORY / TOPICAL, VAGINAL	1999-04-20	`e64feba35796…`

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 · 17 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
miconazole 3	MICONAZOLE NITRATE	Kroger Company	063153cc-00fd-4390-bc68-90b21203678a	2026-02-23	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329 ndc (product): 30142-081
dg health miconazole 3	MICONAZOLE NITRATE	Dolgencorp Inc	d84aa78d-b408-4d51-a54c-c66f6cef33f1	2025-11-01	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329 ndc (product): 55910-081
Miconazole 3	MICONAZOLE NITRATE	Safeway	b32aec61-32c0-4c7f-b843-348243332583	2025-11-01	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
VAGISTAT 3	MICONAZOLE NITRATE	Combe Incorporated	e15a28cd-9e64-4e9e-8df9-829d84f1816c	2025-11-01	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329 ndc (product): 11509-0081
miconazole 3	MICONAZOLE NITRATE	H E B	f24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa6	2025-10-31	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329 ndc (product): 37808-242
CareOne Miconazole 3	MICONAZOLE NITRATE	American Sales Company	84c43793-98e4-4e68-a3bc-3e7222135568	2025-10-23	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329 ndc (product): 41520-154
Miconazole 3	MICONAZOLE NITRATE	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	689ad530-48f9-4044-baa3-4f8b0657aeef	2025-10-23	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
Equate Miconazole 3	MICONAZOLE NITRATE	WALMART INC.	5ade4c65-5757-4f20-b5be-f95d86363d11	2025-09-23	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
Equaline Miconazole 3	MICONAZOLE NITRATE	United Natural Foods, Inc. dba UNFI	89328324-72d9-4b3d-bec7-cc2e4e62f034	2025-09-18	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329 ndc (product): 41163-081
miconazole 3 day	MICONAZOLE NITRATE	Publix Super Markets Inc	9ff23f06-e97f-46ad-8601-97ca05c260a0	2025-09-16	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329 ndc (product): 56062-081
topcare miconazole 3 combination pack	MICONAZOLE NITRATE	Topco Associates LLC	0af4c06a-aa79-48ab-9857-e0f56317d8f3	2025-09-16	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329 ndc (product): 36800-081
miconazole 3	MICONAZOLE NITRATE	Meijer Distribution Inc	feaa0d07-013e-433f-8db4-550dc9ff737e	2025-09-11	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329 ndc (product): 41250-081
Foster and Thrive Miconazole 3	MICONAZOLE NITRATE	Strategic Sourcing Services LLC	ba5d5b13-5604-4b8c-92b9-9f4174458029	2025-08-12	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
Good Neighbor Pharmacy Miconazole 3	MICONAZOLE NITRATE	Amerisource Bergen	5b87b837-3f52-40ca-b2b6-9c1f1262d90d	2025-06-23	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329 ndc (product): 24385-606
Good Sense Miconazole 3	MICONAZOLE NITRATE	L. Perrigo Company	9aeac709-001b-4617-8046-186264847ec8	2025-05-15	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329 ndc (product): 0113-0081
miconazole 3	MICONAZOLE NITRATE	Rite Aid Corporation	4abee369-e8c5-4971-9545-8c015ff6eaad	2023-11-08	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329
Signature Care Miconazole 3	MICONAZOLE NITRATE	Safeway	191e448b-0410-4102-82ae-a3387b27b227	2021-02-04	Warnings	Exact identifier application applno (ANDA): 075329 application number: ANDA075329 ndc (product): 21130-102

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 55 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0067-2091	Vagistat-3	Miconazole nitrate	Novartis Consumer Health, Inc.	ANDA	Current
0113-0081	Good Sense Miconazole 3	Miconazole nitrate	L. Perrigo Company	ANDA	Current
0113-0081	Good Sense Miconazole 3	Miconazole nitrate	L. Perrigo Company	ANDA	Current
0113-0081	Good Sense Miconazole 3	Miconazole nitrate	L. Perrigo Company	ANDA	Current
0363-0081	Miconazole 3	Miconazole nitrate	Walgreen Company	ANDA	Current
0363-0081	Miconazole 3	Miconazole nitrate	Walgreen Company	ANDA	Current
0363-0081	Miconazole 3	Miconazole nitrate	Walgreen Company	ANDA	Current
11509-0081	VAGISTAT 3	Miconazole nitrate	Combe Incorporated	ANDA	Current
11509-0081	VAGISTAT 3	Miconazole nitrate	Combe Incorporated	ANDA	Current
11509-0081	VAGISTAT 3	Miconazole nitrate	Combe Incorporated	ANDA	Current
11673-081	Up and Up Miconazole 3	Miconazole nitrate	Target Corporation	ANDA	Current
21130-102	Signature Care Miconazole 3	Miconazole nitrate	Safeway	ANDA	Current
21130-102	Signature Care Miconazole 3	Miconazole nitrate	Safeway	ANDA	Current
24385-606	Good Neighbor Pharmacy Miconazole Nitrate	Miconazole nitrate	Amerisource Bergen	ANDA	Current
24385-606	Good Neighbor Pharmacy Miconazole Nitrate	Miconazole nitrate	Amerisource Bergen	ANDA	Current
30142-081	miconazole 3	Miconazole nitrate	Kroger Company	ANDA	Current
30142-081	miconazole 3	Miconazole nitrate	Kroger Company	ANDA	Current
30142-081	miconazole 3	Miconazole nitrate	Kroger Company	ANDA	Current
36800-081	topcare miconazole 3	Miconazole nitrate	Topco Associates LLC	ANDA	Current
36800-081	topcare miconazole 3	Miconazole nitrate	Topco Associates LLC	ANDA	Current
36800-081	topcare miconazole 3	Miconazole nitrate	Topco Associates LLC	ANDA	Current
37808-242	miconazole 3	Miconazole nitrate	H E B	ANDA	Current
37808-242	miconazole 3	Miconazole nitrate	H E B	ANDA	Current
41163-081	Equaline Miconazole 3	Miconazole nitrate	Supervalu Inc	ANDA	Current
41163-081	Equaline Miconazole 3	Miconazole nitrate	Supervalu Inc	ANDA	Current
41250-081	miconazole 3	Miconazole nitrate	Meijer Distribution Inc	ANDA	Current
41250-081	miconazole 3	Miconazole nitrate	Meijer Distribution Inc	ANDA	Current
41250-081	miconazole 3	Miconazole nitrate	Meijer Distribution Inc	ANDA	Current
41520-154	CareOne Miconazole 3	Miconazole nitrate	American Sales Company	ANDA	Current
41520-154	CareOne Miconazole 3	Miconazole nitrate	American Sales Company	ANDA	Current
41520-154	CareOne Miconazole 3	Miconazole nitrate	American Sales Company	ANDA	Current
49348-354	sunmark miconazole 3	Miconazole nitrate	McKesson	ANDA	Current
49348-355	sunmark miconazole 3	Miconazole nitrate	McKesson	ANDA	Current
49348-355	sunmark miconazole 3	Miconazole nitrate	Strategic Sourcing Services LLC	ANDA	Current
49348-355	sunmark miconazole 3	Miconazole nitrate	Strategic Sourcing Services LLC	ANDA	Current
49348-355	sunmark miconazole 3	Miconazole nitrate	Strategic Sourcing Services LLC	ANDA	Current
49738-639	Smart Sense Miconazole 3	Miconazole nitrate	Kmart Corporation	ANDA	Current
55316-081	healthy accents miconazole 3	Miconazole nitrate	DZA Brands LLC	ANDA	Current
55316-081	healthy accents miconazole 3	Miconazole nitrate	DZA Brands LLC	ANDA	Current
55316-081	healthy accents miconazole 3	Miconazole nitrate	DZA Brands LLC	ANDA	Current
55319-081	Family Wellness Miconazole 3	Miconazole nitrate	Family Dollar Services Inc	ANDA	Current
55319-081	Family Wellness Miconazole 3	Miconazole nitrate	Family Dollar Services Inc	ANDA	Current
55319-081	Family Wellness Miconazole 3	Miconazole nitrate	Family Dollar Services Inc	ANDA	Current
55319-081	Family Wellness Miconazole 3	Miconazole nitrate	Family Dollar Services Inc	ANDA	Current
55910-081	dg health miconazole 3	Miconazole nitrate	Dolgencorp Inc	ANDA	Current
55910-081	dg health miconazole 3	Miconazole nitrate	Dolgencorp Inc	ANDA	Current
55910-707	rexall miconazole 3	Miconazole nitrate	Dolgencorp Inc	ANDA	Current
56062-081	miconazole 3 day	Miconazole nitrate	Publix Super Markets Inc	ANDA	Current
56062-081	miconazole 3 day	Miconazole nitrate	Publix Super Markets Inc	ANDA	Current
56062-081	miconazole 3 day	Miconazole nitrate	Publix Super Markets Inc	ANDA	Current
56062-081	miconazole 3 day	Miconazole nitrate	Publix Super Markets Inc	ANDA	Current
69256-081	Harris Teeter Miconazole 3	Miconazole nitrate	Harris Teeter, LLC	ANDA	Current
76413-352	Vagistat-3	Miconazole nitrate	Central Texas Community Health Centers	ANDA	Current
80584-081	STIX 3 DAY YEAST INFECTION TREATMENT	Miconazole nitrate	Get Stix Inc.	ANDA	Current
81522-081	caring mill miconazole 3	Miconazole nitrate	FSA Store Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39480	ORIG	2004-06-09
42980	ORIG	2001-12-18
8622	ORIG	1999-04-20