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 42.

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A079114-001MICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINAL2010-06-02caaa826d4ba7…
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…

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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FOSTER AND THRIVE MICONAZOLE 1MICONAZOLE NITRATEStrategic Sourcing Services LLC0d3fcb1a-54dd-49b7-b776-4366fc2147b32026-08-12WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
miconazole 1MICONAZOLE NITRATEKroger Company11878a63-93e7-464f-97fc-54899884d7fe2026-08-11WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
ndc (product): 30142-199
topcare miconazole 1MICONAZOLE NITRATETopco Associates LLC8138de63-c7e9-4b2c-a0e2-c62292a0b3202026-08-11WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
ndc (product): 36800-199
MICONAZOLE 1MICONAZOLE NITRATESafewaybd756451-6f63-4475-9d9a-7fef6a9e5ebf2026-08-03WarningsExact identifier
application applno (ANDA): 079114
application number: ANDA079114
equate miconazole 1MICONAZOLE NITRATEWal-Mart Stores Inc5c5b0486-9ec2-4e14-a35c-80da8e62c59e2026-07-06WarningsExact 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 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