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 42.

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020574-001GYNE-LOTRIMIN 32%CREAM / VAGINALRLD1998-11-24caaa826d4ba7…
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…

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 2 of 9 · 175 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
FifthPulse Clotrimazole AntifungalCLOTRIMAZOLEWeCare Products LLC9f5ea297-5a25-42cc-bd47-4159108b00232026-04-27WarningsName fallback
generic name: CLOTRIMAZOLE
SimplyVital Antifungal ClotrimazoleCLOTRIMAZOLEAlpha Plants Inc44881106-3ab4-4103-9c48-1da435ab5b132026-04-16WarningsName fallback
generic name: CLOTRIMAZOLE
ClotrimazoleCLOTRIMAZOLEPreferred Pharmaceuticals Inc.70e1efac-1738-43db-b19c-bbe02810b6e72026-04-01WarningsName fallback
generic name: CLOTRIMAZOLE
RUGBY ANTIFUNGAL CLOTRIMAZOLECLOTRIMAZOLEPreferred Pharmaceuticals Inc.caba588a-13df-4035-ac41-6b4ec90cd88d2026-04-01WarningsName fallback
generic name: CLOTRIMAZOLE
ClotrimazoleCLOTRIMAZOLEPreferred Pharmaceuticals Inc.80d67df3-843d-47bb-85a2-d2f26a8243362026-03-31WarningsName fallback
generic name: CLOTRIMAZOLE
RoyceDerm Antifungal BarCLOTRIMAZOLERoyceDerm LLC3abdc4a8-58dd-5bd0-e063-6294a90a1bca2026-03-31WarningsName fallback
generic name: CLOTRIMAZOLE
ClotrimazoleCLOTRIMAZOLEPreferred Pharmaceuticals, Inc.624827d6-dbf8-4f3d-a8c0-c92474cad7de2026-03-31WarningsName fallback
generic name: CLOTRIMAZOLE
ClotrimazoleCLOTRIMAZOLEPreferred Pharmaceuticals Inc.fd010006-f646-46ed-841a-9f247b19e3972026-03-31WarningsName fallback
generic name: CLOTRIMAZOLE
AntifungalCLOTRIMAZOLEDynarex Corporation4d4cc4b4-c0b4-9e25-e063-6294a90a70b82026-03-18WarningsName fallback
generic name: CLOTRIMAZOLE
Tagrid Antifungal Jock Itch Cream Non-Steroidal Clotrimazole 1%CLOTRIMAZOLETAGRID LLC4581d0c9-1f85-42c8-87d7-5f38fbbc923a2026-03-15WarningsName fallback
generic name: CLOTRIMAZOLE
CLOTIC (clotrimazole) otic solutionCLOTRIMAZOLECarwin Pharmaceutical Associates, LLCef0658c3-9c6b-4705-89d8-cf0644c80fcb2026-03-03Warnings, Adverse reactionsName fallback
generic name: CLOTRIMAZOLE
ClotrimazoleCLOTRIMAZOLETRIFECTA PHARMACEUTICALS USA LLCe0a2a907-9c3a-4c4e-e053-2995a90abb912026-03-01WarningsName fallback
generic name: CLOTRIMAZOLE
CLOTRIMAZOLECLOTRIMAZOLEAARNA USA INC4bd825f4-f5e2-aab7-e063-6394a90ad6a42026-02-27Warnings, Adverse reactionsName fallback
generic name: CLOTRIMAZOLE
Megababe Fun Gal Stuff AntifungalCLOTRIMAZOLEMegababe LLCc599d27b-fdb0-465f-9e43-13d32c520a922026-02-25WarningsName fallback
generic name: CLOTRIMAZOLE
ClotrimazoleCLOTRIMAZOLEPreferred Pharmaceuticals Inc.d6f5c6b5-5e56-462f-8c47-7986ce53669d2026-02-25WarningsName fallback
generic name: CLOTRIMAZOLE
Kerova ANTIFUNGALCLOTRIMAZOLEGuangzhou Bixiaoyu Trading Co., Ltd.4a7b48cf-72c3-be63-e063-6394a90a1efe2026-02-10WarningsName fallback
generic name: CLOTRIMAZOLE
CLOTRIMAZOLE 1%CLOTRIMAZOLEPHARMACY CHOICE INC43852cfb-6d28-e54f-e063-6394a90aa0902026-02-08WarningsName fallback
generic name: CLOTRIMAZOLE
ClotrimazoleCLOTRIMAZOLEGlenmark Pharmaceuticals Inc., USAf6898117-14f3-42d2-bc0e-d296add3ad702026-01-30Warnings, Adverse reactionsName 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