FDA.reportPublic FDA data

Application 074926

Type
ANDA
Sponsor
P AND L

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001M-ZOLE 3 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
A074926-001M-ZOLE 3 COMBINATION PACKMICONAZOLE NITRATE2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16

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 UTC2022-10A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A074926-001M-ZOLE 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINAL1999-04-16a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Miconazole 3 Combination PackMICONAZOLE NITRATEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)50f2a26c-8203-4a10-8d0d-ad0f9fadb6bc2025-09-08WarningsExact identifier
application applno (ANDA): 074926
application number: ANDA074926
ndc (product): 49035-345
Miconazole 3 Combination PackMICONAZOLE NITRATEChain Drug Consortium, LLCd01f7ef9-4f04-4874-a625-0335f6392b732025-09-05WarningsExact identifier
application applno (ANDA): 074926
application number: ANDA074926
ndc (product): 68016-731
MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kitMICONAZOLE NITRATECosette Pharmaceuticals, Inc.eed88487-a7ba-4853-8519-13f92ed5539f2025-01-06WarningsExact identifier
application applno (ANDA): 074926
application number: ANDA074926

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 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-9089Miconazole 3 Combination Packmiconazole nitrateWalgreensANDACurrent
0904-5415Miconazole 3 Combination Packmiconazole nitrateMajor PharmaceuticalsANDACurrent
0904-5415Miconazole 3 Combination Packmiconazole nitrateMajor PharmaceuticalsANDACurrent
0904-5415Miconazole 3 Combination Packmiconazole nitrateMajor PharmaceuticalsANDACurrent
0904-5415Miconazole 3 Combination Packmiconazole nitrateMajor PharmaceuticalsANDACurrent
0904-5415Miconazole 3 Combination Packmiconazole nitrateMajor PharmaceuticalsANDACurrent
11822-7310Miconazole 3 Combination PackMiconazole NitrateRite AidANDACurrent
11822-7310Miconazole 3 Combination PackMiconazole NitrateRite Aid CorporationANDACurrent
11822-7310Miconazole 3 Combination PackMiconazole NitrateRite Aid CorporationANDACurrent
11822-7310Miconazole 3 Combination PackMiconazole NitrateRite Aid CorporationANDACurrent
37205-583Miconazole 3 Combination Packmiconazole nitrateCardinal Health (Leader) 37205ANDACurrent
37205-583Miconazole 3 Combination Packmiconazole nitrateCardinal Health (Leader) 37205ANDACurrent
37205-583Miconazole 3 Combination Packmiconazole nitrateCARDINAL HEALTHANDACurrent
37205-589Miconazole 3 Combination Packmiconazole nitrateCARDINAL HEALTHANDACurrent
37205-589Miconazole 3 Combination Packmiconazole nitrateCardinal Health (Leader) 37205ANDACurrent
37205-589Miconazole 3 Combination Packmiconazole nitrateCardinal Health (Leader) 37205ANDACurrent
49035-345Miconazole 3 Combination PackMiconazole NitrateEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)ANDACurrent
49035-345Miconazole 3 Combination PackMiconazole NitrateEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-345Miconazole 3 Combination PackMiconazole NitrateEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-731Miconazole 3 Combination PackMiconazole NitrateWal-Mart Stores IncANDACurrent
49035-731Miconazole 3 Combination PackMiconazole NitrateEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
59726-989Miconazole 3 Combination PackMiconazole NitrateP & L Development, LLCANDACurrent
59779-773Miconazole 3 Combination PackMiconazole NitrateCVS PharmacyANDACurrent
59779-773Miconazole 3 Combination PackMiconazole NitrateCVS PharmacyANDACurrent
59779-773Miconazole 3 Combination PackMiconazole NitrateCVS PharmacyANDACurrent
59779-773Miconazole 3 Combination PackMiconazole NitrateCVS PharmacyANDACurrent
68016-731Miconazole 3 Combination PackMiconazole NitrateChain Drug Consortium, LLCANDACurrent
68016-731Miconazole 3 Combination PackMiconazole NitrateChain Drug Consortium, LLCANDACurrent
68016-731Miconazole 3 Combination PackMiconazole NitrateChain Drug Consortium, LLCANDACurrent
68016-731Miconazole 3 Combination PackMiconazole NitrateChain Drug Consortium, LLCANDACurrent
68016-731Miconazole 3 Combination PackMiconazole NitrateChain Drug Consortium, LLCANDACurrent
70000-0025Miconazole 3 Combination Packmiconazole nitrateCardinal Health (Leader) 70000ANDACurrent
70000-0025Miconazole 3 Combination Packmiconazole nitrateCardinal Health (Leader) 70000ANDACurrent
70000-0025Miconazole 3 Combination Packmiconazole nitrateCardinal Health (Leader) 70000ANDACurrent
70000-0025Miconazole 3 Combination Packmiconazole nitrateCardinal Health (Leader) 70000ANDACurrent
70000-0025Miconazole 3 Combination Packmiconazole nitrateCardinal Health (Leader) 70000ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18372ORIG2004-06-09
22384ORIG2002-01-14
30719ORIG1999-04-16