FDA.reportPublic FDA data

Application 021308

Type
NDA
Sponsor
MEDTECH PRODUCTS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MONISTAT 1 COMBINATION PACKMICONAZOLE NITRATECREAM, SUPPOSITORY;TOPICAL, VAGINAL2%,1.2GMYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N021308-001MONISTAT 1 COMBINATION PACKMICONAZOLE NITRATE2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021308-001MONISTAT 1 COMBINATION PACK2%,1.2GMCREAM, INSERT / TOPICAL, VAGINALRLD, RS2001-06-29a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021308-00161536352020-11-28Delist requested74a2ff9319b5…
2020-12-22 03:56 UTC2020-12N021308-00161536352020-11-28Delist requested8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021308-00161536352020-11-28Delist requestedc0c555d07b60…
2019-12-14 00:12 UTC2019-12N021308-00161536352020-11-28Delist requested3f01610625f2…
2019-09-15 20:21 UTC2019-09N021308-00161536352020-11-28Delist requestedb00525d2431f…
2019-07-19 19:46 UTC2019-07N021308-00161536352020-11-28Delist requestedea99ee380514…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Miconazole 1 WalgreensMICONAZOLE NITRATEWALGREEN COMPANY9679f4a5-c27b-46ea-9983-c2a111d3d2c32026-05-06WarningsExact identifier
application applno (NDA): 021308
application number: NDA021308
Monistat 1 Combination PackMICONAZOLE NITRATEInsight Pharmaceuticals LLC97ff1c90-c250-4921-81af-6a56cc9cc7d22026-04-20WarningsExact identifier
application applno (NDA): 021308
application number: NDA021308
ndc (product): 63736-013
CVS MICONAZOLE 1 COMBINATION PACKMICONAZOLE NITRATECVS PHARMACY, INCdb40f672-62b4-4844-a2d3-7e8617c40ec92026-03-24WarningsExact identifier
application applno (NDA): 021308
application number: NDA021308
Miconazole 1 WalgreensMICONAZOLE NITRATEWALGREEN COMPANY1fe7b02a-f60b-4572-b4e8-35bda290b1762026-01-23WarningsExact identifier
application applno (NDA): 021308
application number: NDA021308
ndc (product): 0363-5201

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-5201Miconazole 1Miconazole NitrateWALGREEN COMPANYNDACurrent
63736-001Monistat 1 Combination PackMiconazole NitrateInsight PharmaceuticalsNDACurrent
63736-013Monistat 1 Combination PackMiconazole NitrateInsight PharmaceuticalsNDACurrent
63736-013Monistat 1 Combination PackMiconazole NitrateInsight Pharmaceuticals LLCNDACurrent
63736-014Monistat 1 Combination PackMiconazole NitrateInsight PharmaceuticalsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70549SUPPL2022-03-17
70399SUPPL2022-03-04
61731SUPPL2020-01-29
61730SUPPL2020-01-29
49512SUPPL2017-08-22
21590SUPPL2007-11-19
27449SUPPL2005-04-06
36632SUPPL2004-10-05
27448SUPPL2004-10-05
27447SUPPL2004-06-09
27446ORIG2004-06-09
21589ORIG2004-06-09
4996SUPPL2004-06-09
4997SUPPL2003-12-08
15162ORIG2003-05-07