FDA.reportPublic FDA data

Application 020574

Type
NDA
Sponsor
BAYER HEALTHCARE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GYNE-LOTRIMIN 3CLOTRIMAZOLECREAM;VAGINAL2%YesNo

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
N020574-001GYNE-LOTRIMIN 3CLOTRIMAZOLE2%CREAM / VAGINALRLD1998-11-24

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 UTC2026-02N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-2487673890dc5c…
2021-03-12 10:30 UTC2021-03N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-243f01610625f2…
2019-09-15 20:21 UTC2019-09N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-24b00525d2431f…
2019-07-19 19:46 UTC2019-07N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-243f0d92c62455…
2023-05-13 08:27 UTC2023-05N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-24053a50430f4f…
2023-01-26 05:58 UTC2023-01N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-24cb3db0bc1861…

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 9 · 173 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ClotrimazoleCLOTRIMAZOLEShaanxi Shuvita Biotech Co., Ltd572a5f3d-fb46-5dfa-e063-6294a90a722b2026-07-21WarningsName fallback
generic name: CLOTRIMAZOLE
Tea Tree AntifungalCLOTRIMAZOLEHONG KONG UNORDERED TRADING CO., LIMITED56de35b7-b57d-1c62-e063-6294a90a757d2026-07-18WarningsName fallback
generic name: CLOTRIMAZOLE
ClotrimazoleCLOTRIMAZOLEPreferred Pharmaceuticals Inc.c64e2290-593f-48a2-a15d-41689f836fda2026-07-16Warnings, Adverse reactionsName fallback
generic name: CLOTRIMAZOLE
terrasil Antifungal Cleansing BarCLOTRIMAZOLEAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions10a4fde0-87e1-4474-bcb5-255b0a7f1ecb2026-07-14WarningsName fallback
generic name: CLOTRIMAZOLE
Tinea Versicolor Treatment CreamCLOTRIMAZOLEBeautivity LLC32d71d7e-3c78-6b63-e063-6294a90adaed2026-06-29WarningsName fallback
generic name: CLOTRIMAZOLE
Tinea Versicolor Treatment BarCLOTRIMAZOLEBeautivity LLC33612382-2f12-e9f6-e063-6394a90aaee42026-06-29WarningsName fallback
generic name: CLOTRIMAZOLE
Tinea Versicolor Treatment KitCLOTRIMAZOLEBeautivity LLC3361d9a2-daf6-7749-e063-6294a90a36532026-06-29WarningsName fallback
generic name: CLOTRIMAZOLE
Terramed Just Think Comfort Clotrimazole Antifungal Topical SolutionCLOTRIMAZOLERida LLC83a9c5dc-c969-43a7-a763-44783710d5d02026-06-18WarningsName fallback
generic name: CLOTRIMAZOLE
ClotrimazoleCLOTRIMAZOLERedpharm Drug53cafc9f-7761-83a9-e063-6294a90a34372026-06-09Warnings, Adverse reactionsName fallback
generic name: CLOTRIMAZOLE
ClotrimazoleCLOTRIMAZOLEWalgreens7ca79361-6608-4eda-ba5b-16c28eb6c0192026-06-09WarningsName fallback
generic name: CLOTRIMAZOLE
ClotrimazoleCLOTRIMAZOLESun Pharmaceutical Industries, Inc.13a14d3c-bfce-42b5-8463-4ec69e94774e2026-06-03WarningsName fallback
generic name: CLOTRIMAZOLE
Athletes Foot CreamCLOTRIMAZOLEShenzhen Miandou Technology Co.,Ltd.53451e74-719e-9499-e063-6394a90a9e5a2026-06-02WarningsName fallback
generic name: CLOTRIMAZOLE
Medi-First Clotrimazole 1% ANTIFUNGAL CreamCLOTRIMAZOLEUnifirst First Aid Corporation522eeb91-8378-32f4-e063-6394a90aff432026-05-20WarningsName fallback
generic name: CLOTRIMAZOLE
Fungicure IntensiveCLOTRIMAZOLEKobayashi Healthcare International, Inc.1f1b413f-278e-434f-8590-4cf731663f5c2026-05-15WarningsName fallback
generic name: CLOTRIMAZOLE
Tagrid Feminine Itch Relief Cream Antifungal Formula Clotrimazole 1%CLOTRIMAZOLETAGRID LLCfe76e89c-470c-4903-bc8d-3fcdaee47d5a2026-05-15WarningsName fallback
generic name: CLOTRIMAZOLE
Tagrid Intertrigo Cream For Skin Fold Rash Clotrimazole 1%CLOTRIMAZOLETAGRID LLCd40453ba-cbd4-4087-98af-3ac721a55ab42026-05-15WarningsName fallback
generic name: CLOTRIMAZOLE
CLOTRIMAZOLECLOTRIMAZOLERugby Laboratories, Inc.2c60e631-5930-4420-886d-eb1990c720b62026-05-11WarningsName fallback
generic name: CLOTRIMAZOLE
clotrimazoleCLOTRIMAZOLEA-S Medication Solutionsc0f58a0d-a304-41f9-bbdf-c2e488230cf02026-05-11WarningsName fallback
generic name: CLOTRIMAZOLE
ClotrimazoleCLOTRIMAZOLEAkron Pharma Inc692d7e0f-50d4-4abb-8c74-36bc98064fe72026-05-05WarningsName fallback
generic name: CLOTRIMAZOLE
ClotrimazoleCLOTRIMAZOLEKJD Pharma Private Limited5115f8e3-5668-5207-e063-6394a90a76502026-05-05WarningsName fallback
generic name: CLOTRIMAZOLE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
34872SUPPL2010-04-13
2763SUPPL2010-04-13
34871ORIG1998-11-24
25216ORIG1998-11-24
20733ORIG1998-11-24