FDA.reportPublic FDA data

Application 079114

Type
ANDA
Sponsor
PERRIGO R AND D

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MICONAZOLE NITRATEMICONAZOLE NITRATECREAM, SUPPOSITORY;TOPICAL, VAGINAL2%,1.2GMNoNo
002MICONAZOLE NITRATEMICONAZOLE NITRATECREAM; TOPICAL, VAGINAL2%YesNo

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
A079114-001MICONAZOLE NITRATEMICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINAL2010-06-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINAL2010-06-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINAL2010-06-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINAL2010-06-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINAL2010-06-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINAL2010-06-023f01610625f2…
2019-09-15 20:21 UTC2019-09A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINAL2010-06-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, SUPPOSITORY / TOPICAL, VAGINAL2010-06-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02cb3db0bc1861…

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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FOSTER AND THRIVE MICONAZOLE 1MICONAZOLE NITRATEStrategic Sourcing Services LLC0d3fcb1a-54dd-49b7-b776-4366fc2147b32025-10-01WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
equate miconazole 1MICONAZOLE NITRATEWal-Mart Stores Inc5c5b0486-9ec2-4e14-a35c-80da8e62c59e2025-07-02WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
ndc (product): 49035-199
miconazole 1MICONAZOLE NITRATEMeijer Distribution Incc34d9917-ee79-4afb-9338-6f18e63b2b092025-01-13WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
ndc (product): 41250-199
up and up miconazoleMICONAZOLE NITRATETarget Corporationb626313a-b8aa-43fe-b8a9-475009ea5b532024-12-11WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
ndc (product): 11673-199
miconazole 1MICONAZOLE NITRATEKroger Company11878a63-93e7-464f-97fc-54899884d7fe2024-12-11WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
ndc (product): 30142-199
topcare miconazole 1MICONAZOLE NITRATETopco Associates LLC8138de63-c7e9-4b2c-a0e2-c62292a0b3202024-12-11WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
ndc (product): 36800-199
miconazole 1 yeast infection reliefMICONAZOLE NITRATECVS Pharmacyb0e5320b-73d5-4e96-8ce4-9a858e9d2ed32024-12-10WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
ndc (product): 59779-199
Basic Care MiconazoleMICONAZOLE NITRATEAmazon.com Services LLC962bef75-1583-4782-bfba-52a68876eedc2024-11-04WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
ndc (product): 72288-199
careone miconazole 1MICONAZOLE NITRATEAmerican Sales Companyf51af8e2-fb06-4842-8021-b7efd515022e2023-10-23WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
ndc (product): 41520-616
exchange select miconazole 1MICONAZOLE NITRATEArmy & Air Force Exchange Service672d935f-0807-44d1-8faa-94d4169070952022-11-29WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
ndc (product): 55301-211
Signature Care Miconazole 1MICONAZOLE NITRATESafeway5129e042-421e-41e3-a0be-90f12d12b40b2022-11-15WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
ndc (product): 21130-040
miconazole 1MICONAZOLE NITRATEH E B40cc911b-2c35-4382-a979-fb1a165049db2022-11-12WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
ndc (product): 37808-199
Good Neighbor Pharmacy Miconazole 1MICONAZOLE NITRATEAmerisource Bergen12c400dc-4fbf-4a10-9a4d-5156d65b509a2022-11-09WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
ndc (product): 46122-577

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 70 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-0916good sense miconazole 1Miconazole nitrateL. Perrigo CompanyANDACurrent
0113-7199Basic Care miconazole 1Miconazole nitrateL. Perrigo CompanyANDACurrent
0113-7199Basic Care miconazole 1Miconazole nitrateL. Perrigo CompanyANDACurrent
0113-9001good sense miconazole 1Miconazole nitrateL. Perrigo CompanyANDACurrent
0363-0199Miconazole 1Miconazole nitrateWalgreen CompanyANDACurrent
0363-0199Miconazole 1Miconazole nitrateWalgreen CompanyANDACurrent
0363-0737Miconazole 1Miconazole nitrateWalgreen CompanyANDACurrent
0363-0916miconazole 1Miconazole nitrateWalgreen CompanyANDACurrent
11673-199up and up miconazoleMiconazole nitrateTarget CorporationANDACurrent
11673-199up and up miconazoleMiconazole nitrateTarget CorporationANDACurrent
11673-199up and up miconazoleMiconazole nitrateTarget CorporationANDACurrent
11673-199up and up miconazoleMiconazole nitrateTarget CorporationANDACurrent
11673-737Up and Up Miconazole 1Miconazole nitrateTarget CorporationANDACurrent
11822-0199miconazole 1Miconazole nitrateRite Aid CorporationANDACurrent
11822-0737miconazole 1Miconazole nitrateRite Aid CorporationANDACurrent
11822-0916miconazole 1Miconazole nitrateRite Aid CorporationANDACurrent
11822-1104miconazole 1Miconazole nitrateRite Aid CorporationANDACurrent
21130-040Signature Care Miconazole 1Miconazole nitrateSafewayANDACurrent
21130-040Signature Care Miconazole 1Miconazole nitrateSafewayANDACurrent
21130-040Signature Care Miconazole 1Miconazole nitrateSafewayANDACurrent
21130-737Signature Care miconazole 1Miconazole nitrateSafewayANDACurrent
30142-199miconazole 1Miconazole nitrateKroger CompanyANDACurrent
30142-199miconazole 1Miconazole nitrateKroger CompanyANDACurrent
30142-199miconazole 1Miconazole nitrateKroger CompanyANDACurrent
30142-737Miconazole 1Miconazole nitrateKroger CompanyANDACurrent
36800-199topcare miconazole 1Miconazole nitrateTopco Associates LLCANDACurrent
36800-199topcare miconazole 1Miconazole nitrateTopco Associates LLCANDACurrent
36800-199topcare miconazole 1Miconazole nitrateTopco Associates LLCANDACurrent
36800-199topcare miconazole 1Miconazole nitrateTopco Associates LLCANDACurrent
36800-199topcare miconazole 1Miconazole nitrateTopco Associates LLCANDACurrent
36800-737topcare miconazole 1Miconazole nitrateTopco Associates LLCANDACurrent
37808-199miconazole 1Miconazole nitrateH E BANDACurrent
37808-199miconazole 1Miconazole nitrateH E BANDACurrent
37808-199miconazole 1Miconazole nitrateH E BANDACurrent
37808-737miconazole 1Miconazole nitrateH E BANDACurrent
41250-199miconazole 1Miconazole nitrateMeijer Distribution IncANDACurrent
41250-199miconazole 1Miconazole nitrateMeijer Distribution IncANDACurrent
41250-199miconazole 1Miconazole nitrateMeijer Distribution IncANDACurrent
41250-737miconazole 1Miconazole nitrateMeijer Distribution IncANDACurrent
41520-616careone miconazole 1Miconazole nitrateAmerican Sales CompanyANDACurrent
41520-616careone miconazole 1Miconazole nitrateAmerican Sales CompanyANDACurrent
41520-916care one miconazole 1Miconazole nitrateAmerican Sales CompanyANDACurrent
46122-577Good Neighbor Pharmacy Miconazole 1Miconazole nitrateAmerisource BergenANDACurrent
46122-577Good Neighbor Pharmacy Miconazole 1Miconazole nitrateAmerisource BergenANDACurrent
46122-577Good Neighbor Pharmacy Miconazole 1Miconazole nitrateAmerisource BergenANDACurrent
49035-199equate miconazole 1Miconazole nitrateWal-Mart Stores IncANDACurrent
49035-199equate miconazole 1Miconazole nitrateWal-Mart Stores IncANDACurrent
49035-199equate miconazole 1Miconazole nitrateWal-Mart Stores IncANDACurrent
49035-199equate miconazole 1Miconazole nitrateWal-Mart Stores IncANDACurrent
49035-199equate miconazole 1Miconazole nitrateWal-Mart Stores IncANDACurrent
49035-737Equate Miconazole 1Miconazole nitrateWal-Mart Stores IncANDACurrent
49035-737Equate Miconazole 1Miconazole nitrateWal-Mart Stores IncANDACurrent
49738-003image essentials miconazole treatmentMiconazole nitrateKmart CorporationANDACurrent
49738-199Smart Sense miconazole 1Miconazole nitrateKmart CorporationANDACurrent
49738-403Smart Sense Miconazole 1Miconazole nitrateKmart CorporationANDACurrent
49738-823Smart Sense Miconazole 1Miconazole nitrateKmart CorporationANDACurrent
50066-199lagicamMiconazole nitrateGenomma Lab USA, Inc.ANDACurrent
50066-199lagicamMiconazole nitrateGenomma Lab USA, Inc.ANDACurrent
50066-811lagicamMiconazole nitrateGenomma Lab USA, Inc.ANDACurrent
55301-211exchange select miconazole 1Miconazole nitrateArmy & Air Force Exchange ServiceANDACurrent
55301-211exchange select miconazole 1Miconazole nitrateArmy & Air Force Exchange ServiceANDACurrent
55301-211exchange select miconazole 1Miconazole nitrateArmy & Air Force Exchange ServiceANDACurrent
55301-916Exchange Select Miconazole 1Miconazole nitrateArmy & Air Force Exchange ServiceANDACurrent
59779-199miconazole 1Miconazole nitrateCVS PharmacyANDACurrent
59779-199miconazole 1Miconazole nitrateCVS PharmacyANDACurrent
59779-199miconazole 1Miconazole nitrateCVS PharmacyANDACurrent
59779-737Miconazole 1Miconazole nitrateCVS PharmacyANDACurrent
70000-0315Leader Miconazole 1Miconazole nitrateCardinal HealthANDACurrent
72288-199Basic Care MiconazoleMiconazole nitrateAmazon.com Services LLCANDACurrent
72288-199Basic Care MiconazoleMiconazole nitrateAmazon.com Services LLCANDACurrent