FDA.reportPublic FDA data

Application 075329

Type
ANDA
Sponsor
PERRIGO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MICONAZOLE NITRATE COMBINATION PACKMICONAZOLE NITRATECREAM, SUPPOSITORY;TOPICAL, VAGINAL2%,200MGNoNo

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075329-001MICONAZOLE NITRATE COMBINATION PACKMICONAZOLE NITRATE2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-20

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-20a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
miconazole 3MICONAZOLE NITRATEKroger Company063153cc-00fd-4390-bc68-90b21203678a2026-02-23WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329
ndc (product): 30142-081
dg health miconazole 3MICONAZOLE NITRATEDolgencorp Incd84aa78d-b408-4d51-a54c-c66f6cef33f12025-11-01WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329
ndc (product): 55910-081
Miconazole 3MICONAZOLE NITRATESafewayb32aec61-32c0-4c7f-b843-3482433325832025-11-01WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329
VAGISTAT 3MICONAZOLE NITRATECombe Incorporatede15a28cd-9e64-4e9e-8df9-829d84f1816c2025-11-01WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329
ndc (product): 11509-0081
miconazole 3MICONAZOLE NITRATEH E Bf24ec8b6-0d2a-4bf0-9f2b-cad5bee9aaa62025-10-31WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329
ndc (product): 37808-242
CareOne Miconazole 3MICONAZOLE NITRATEAmerican Sales Company84c43793-98e4-4e68-a3bc-3e72221355682025-10-23WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329
ndc (product): 41520-154
Miconazole 3MICONAZOLE NITRATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED689ad530-48f9-4044-baa3-4f8b0657aeef2025-10-23WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329
Equate Miconazole 3MICONAZOLE NITRATEWALMART INC.5ade4c65-5757-4f20-b5be-f95d86363d112025-09-23WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329
Equaline Miconazole 3MICONAZOLE NITRATEUnited Natural Foods, Inc. dba UNFI89328324-72d9-4b3d-bec7-cc2e4e62f0342025-09-18WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329
ndc (product): 41163-081
miconazole 3 dayMICONAZOLE NITRATEPublix Super Markets Inc9ff23f06-e97f-46ad-8601-97ca05c260a02025-09-16WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329
ndc (product): 56062-081
topcare miconazole 3 combination packMICONAZOLE NITRATETopco Associates LLC0af4c06a-aa79-48ab-9857-e0f56317d8f32025-09-16WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329
ndc (product): 36800-081
miconazole 3MICONAZOLE NITRATEMeijer Distribution Incfeaa0d07-013e-433f-8db4-550dc9ff737e2025-09-11WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329
ndc (product): 41250-081
Foster and Thrive Miconazole 3MICONAZOLE NITRATEStrategic Sourcing Services LLCba5d5b13-5604-4b8c-92b9-9f41744580292025-08-12WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329
Good Neighbor Pharmacy Miconazole 3MICONAZOLE NITRATEAmerisource Bergen5b87b837-3f52-40ca-b2b6-9c1f1262d90d2025-06-23WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329
ndc (product): 24385-606
Good Sense Miconazole 3MICONAZOLE NITRATEL. Perrigo Company9aeac709-001b-4617-8046-186264847ec82025-05-15WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329
ndc (product): 0113-0081
miconazole 3MICONAZOLE NITRATERite Aid Corporation4abee369-e8c5-4971-9545-8c015ff6eaad2023-11-08WarningsExact identifier
application applno (ANDA): 075329
application number: ANDA075329
Signature Care Miconazole 3MICONAZOLE NITRATESafeway191e448b-0410-4102-82ae-a3387b27b2272021-02-04WarningsExact 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
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0067-2091Vagistat-3Miconazole nitrateNovartis Consumer Health, Inc.ANDACurrent
0113-0081Good Sense Miconazole 3Miconazole nitrateL. Perrigo CompanyANDACurrent
0113-0081Good Sense Miconazole 3Miconazole nitrateL. Perrigo CompanyANDACurrent
0113-0081Good Sense Miconazole 3Miconazole nitrateL. Perrigo CompanyANDACurrent
0363-0081Miconazole 3Miconazole nitrateWalgreen CompanyANDACurrent
0363-0081Miconazole 3Miconazole nitrateWalgreen CompanyANDACurrent
0363-0081Miconazole 3Miconazole nitrateWalgreen CompanyANDACurrent
11509-0081VAGISTAT 3Miconazole nitrateCombe IncorporatedANDACurrent
11509-0081VAGISTAT 3Miconazole nitrateCombe IncorporatedANDACurrent
11509-0081VAGISTAT 3Miconazole nitrateCombe IncorporatedANDACurrent
11673-081Up and Up Miconazole 3Miconazole nitrateTarget CorporationANDACurrent
21130-102Signature Care Miconazole 3Miconazole nitrateSafewayANDACurrent
21130-102Signature Care Miconazole 3Miconazole nitrateSafewayANDACurrent
24385-606Good Neighbor Pharmacy Miconazole NitrateMiconazole nitrateAmerisource BergenANDACurrent
24385-606Good Neighbor Pharmacy Miconazole NitrateMiconazole nitrateAmerisource BergenANDACurrent
30142-081miconazole 3Miconazole nitrateKroger CompanyANDACurrent
30142-081miconazole 3Miconazole nitrateKroger CompanyANDACurrent
30142-081miconazole 3Miconazole nitrateKroger CompanyANDACurrent
36800-081topcare miconazole 3Miconazole nitrateTopco Associates LLCANDACurrent
36800-081topcare miconazole 3Miconazole nitrateTopco Associates LLCANDACurrent
36800-081topcare miconazole 3Miconazole nitrateTopco Associates LLCANDACurrent
37808-242miconazole 3Miconazole nitrateH E BANDACurrent
37808-242miconazole 3Miconazole nitrateH E BANDACurrent
41163-081Equaline Miconazole 3Miconazole nitrateSupervalu IncANDACurrent
41163-081Equaline Miconazole 3Miconazole nitrateSupervalu IncANDACurrent
41250-081miconazole 3Miconazole nitrateMeijer Distribution IncANDACurrent
41250-081miconazole 3Miconazole nitrateMeijer Distribution IncANDACurrent
41250-081miconazole 3Miconazole nitrateMeijer Distribution IncANDACurrent
41520-154CareOne Miconazole 3Miconazole nitrateAmerican Sales CompanyANDACurrent
41520-154CareOne Miconazole 3Miconazole nitrateAmerican Sales CompanyANDACurrent
41520-154CareOne Miconazole 3Miconazole nitrateAmerican Sales CompanyANDACurrent
49348-354sunmark miconazole 3Miconazole nitrateMcKessonANDACurrent
49348-355sunmark miconazole 3Miconazole nitrateMcKessonANDACurrent
49348-355sunmark miconazole 3Miconazole nitrateStrategic Sourcing Services LLCANDACurrent
49348-355sunmark miconazole 3Miconazole nitrateStrategic Sourcing Services LLCANDACurrent
49348-355sunmark miconazole 3Miconazole nitrateStrategic Sourcing Services LLCANDACurrent
49738-639Smart Sense Miconazole 3Miconazole nitrateKmart CorporationANDACurrent
55316-081healthy accents miconazole 3Miconazole nitrateDZA Brands LLCANDACurrent
55316-081healthy accents miconazole 3Miconazole nitrateDZA Brands LLCANDACurrent
55316-081healthy accents miconazole 3Miconazole nitrateDZA Brands LLCANDACurrent
55319-081Family Wellness Miconazole 3Miconazole nitrateFamily Dollar Services IncANDACurrent
55319-081Family Wellness Miconazole 3Miconazole nitrateFamily Dollar Services IncANDACurrent
55319-081Family Wellness Miconazole 3Miconazole nitrateFamily Dollar Services IncANDACurrent
55319-081Family Wellness Miconazole 3Miconazole nitrateFamily Dollar Services IncANDACurrent
55910-081dg health miconazole 3Miconazole nitrateDolgencorp IncANDACurrent
55910-081dg health miconazole 3Miconazole nitrateDolgencorp IncANDACurrent
55910-707rexall miconazole 3Miconazole nitrateDolgencorp IncANDACurrent
56062-081miconazole 3 dayMiconazole nitratePublix Super Markets IncANDACurrent
56062-081miconazole 3 dayMiconazole nitratePublix Super Markets IncANDACurrent
56062-081miconazole 3 dayMiconazole nitratePublix Super Markets IncANDACurrent
56062-081miconazole 3 dayMiconazole nitratePublix Super Markets IncANDACurrent
69256-081Harris Teeter Miconazole 3Miconazole nitrateHarris Teeter, LLCANDACurrent
76413-352Vagistat-3Miconazole nitrateCentral Texas Community Health CentersANDACurrent
80584-081STIX 3 DAY YEAST INFECTION TREATMENTMiconazole nitrateGet Stix Inc.ANDACurrent
81522-081caring mill miconazole 3Miconazole nitrateFSA Store Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39480ORIG2004-06-09
42980ORIG2001-12-18
8622ORIG1999-04-20