FDA.reportPublic FDA data

Application 020670

Type
NDA
Sponsor
MEDTECH PRODUCTS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002MONISTAT 3 COMBINATION PACKMICONAZOLE NITRATECREAM, SUPPOSITORY;TOPICAL, VAGINAL2%,200MGYesYes

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
N020670-002MONISTAT 3 COMBINATION PACKMICONAZOLE NITRATE2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16

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 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 UTC2026-02N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-1687673890dc5c…
2021-03-12 10:30 UTC2021-03N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-163f01610625f2…
2019-09-15 20:21 UTC2019-09N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16b00525d2431f…
2019-07-19 19:46 UTC2019-07N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-163f0d92c62455…
2023-05-13 08:27 UTC2023-05N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16053a50430f4f…
2023-01-26 05:58 UTC2023-01N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020670-002MONISTAT 3 COMBINATION PACK2%,200MGCREAM, SUPPOSITORY / TOPICAL, VAGINALRLD, RS1996-04-16cb3db0bc1861…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Miconazole 3 Walgreen CompanyMICONAZOLE NITRATEWALGREEN COMPANY32b373be-9c8e-49b0-a796-8d87f6a20cef2026-07-21WarningsExact identifier
application applno (NDA): 020670
application number: NDA020670
ndc (product): 0363-5203
Monistat 3 Combination Pack 3 Ovule InsertsMICONAZOLE NITRATEInsight Pharmaceuticals LLC910d81cd-67dc-4fdf-94cf-4eb3b1dca0fd2026-04-20WarningsExact identifier
application applno (NDA): 020670
application number: NDA020670
ndc (product): 63736-019
Miconazole 1 Combination PackMICONAZOLE NITRATECVS PHARMACY, INC4cbf37d1-023d-496f-84c8-a1b2a83a10ef2026-01-29WarningsExact identifier
application applno (NDA): 020670
application number: NDA020670
ndc (product): 51316-005
MONISTAT 3MICONAZOLE NITRATEInsight Pharmaceuticals LLC674f2e66-e7e3-40ff-aa21-adaf5d55dcda2025-11-04WarningsExact identifier
application applno (NDA): 020670
application number: NDA020670
ndc (product): 63736-017
Monistat 3 Combination PackMICONAZOLE NITRATEInsight Pharmaceuticals LLCe1b8ad40-5adb-482a-b532-3f8e30d901282025-10-27WarningsExact identifier
ndc (product): 63736-010
Miconazole 3MICONAZOLE NITRATECVS Pharmacy6e027927-1532-46ba-8839-6ee4416d0b602017-01-06WarningsExact identifier
application applno (NDA): 020670
application number: NDA020670
ndc (product): 69842-950

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-5203Miconazole 3Miconazole nitrateWALGREEN COMPANYNDACurrent
51316-005Miconazole 1 Combination PackMiconazole NitrateCVS PHARMACY, INCNDACurrent
57501-006Monistat 3 Combination PackMiconazole NitrateApex International Mfg., Inc.NDACurrent
63736-002Monistat 3 Combination PackMiconazole NitrateInsight PharmaceuticalsNDACurrent
63736-010Monistat 3 Combination PackMiconazole NitrateInsight Pharmaceuticals LLCNDACurrent
63736-010Monistat 3 Combination PackMiconazole NitrateInsight Pharmaceuticals LLCNDACurrent
63736-016Monistat 3 Combination PackMiconazole NitrateInsight PharmaceuticalsNDACurrent
63736-017MONISTAT 3Miconazole NitrateInsight Pharmaceuticals LLCNDACurrent
63736-018Monistat 3 Combination PackMiconazole NitrateInsight PharmaceuticalsNDACurrent
63736-019Monistat 3 Combination PackMiconazole NitrateInsight Pharmaceuticals LLCNDACurrent
69842-950Miconazole 3Miconazole nitrateCVS PharmacyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76665SUPPL 2023-11-24
76632SUPPL 2023-11-20
70540SUPPL2022-03-17
70398SUPPL2022-03-04
61721SUPPL2020-01-29
61720SUPPL2020-01-29
41536SUPPL2014-07-02
41537SUPPL2012-11-09
13179SUPPL2007-03-23
3052SUPPL2007-03-23
25484SUPPL2003-01-09