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 44.

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-20cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A075329-001MICONAZOLE NITRATE COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-20a50c72e98297…

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 · 16 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
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

Reported adverse events (FAERS/openFDA)#

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

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