FDA.reportPublic FDA data

Application 076773

Type
ANDA
Sponsor
TARO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MICONAZOLE 3MICONAZOLE NITRATECREAM;VAGINAL4%NoNo

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
A076773-001MICONAZOLE 3MICONAZOLE NITRATE4%CREAM / VAGINAL2005-03-02

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 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 UTC2022-10A076773-001MICONAZOLE 34%CREAM / VAGINAL2005-03-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076773-001MICONAZOLE 34%CREAM / VAGINAL2005-03-02e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076773-001MICONAZOLE 34%CREAM / VAGINAL2005-03-02cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A076773-001MICONAZOLE 34%CREAM / VAGINAL2005-03-02a50c72e98297…

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 3MICONAZOLE NITRATETARGET Corporation12a2e441-4fdf-4c5e-b033-ba05ef12fc2f2025-07-18WarningsExact identifier
application applno (ANDA): 076773
application number: ANDA076773
ndc (product): 11673-391
Lagicam antifungalMICONAZOLE NITRATEGenomma Lab USA, Inc.85043273-7411-48f5-8ad4-3f00e03cafa32025-07-02WarningsExact identifier
application applno (ANDA): 076773
application number: ANDA076773
ndc (product): 50066-070
Miconazole NitrateMICONAZOLE NITRATESun Pharmaceutical Industries, Inc.eaca3e39-6ea0-4d7e-803c-db22024ad9f92025-07-01WarningsExact identifier
application applno (ANDA): 076773
application number: ANDA076773
ndc (product): 51672-2070

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 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11673-391Miconazole 3Miconazole NitrateTARGET CorporationANDACurrent
36800-070TopCareMiconazole NitrateTopco Associates LLCANDACurrent
36800-070TopCareMiconazole NitrateTopco Associates LLCANDACurrent
37012-070Miconazole 3Miconazole NitrateShopko Stores Operating Co., LLCANDACurrent
41250-491meijerMiconazole NitrateMeijer Distribution IncANDACurrent
50066-070LagicamMiconazole NitrateGenomma Lab USA, Inc.ANDACurrent
50066-070LagicamMiconazole NitrateGenomma Lab USA, Inc.ANDACurrent
51672-2070Miconazole NitrateMiconazole NitrateTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-2070Miconazole NitrateMiconazole NitrateTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
51672-2070Miconazole NitrateMiconazole NitrateTaro Pharmaceuticals U.S.A., Inc.ANDACurrent
55315-737FredsMiconazole NitrateFRED'S, INC.ANDACurrent
63868-197Quality ChoiceMiconazole NitrateChain Drug Marketing AssociationANDACurrent
68016-070Premier ValueMiconazole NitratePharmacy Value Alliance LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31164ORIG2005-03-03