Viewing data from:

CLOTRIMAZOLE

ANDA

CLOTRIMAZOLE | A074165 | ENCUBE ETHICALS PRIVATE LTD

1 strength0 unique patents0 unique exclusivities

API Supply Chain6 active DMFs6 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

ERREGIERRE SPACLOTRIMAZOLE USP-EP

DMF 63241986

FIS FABBRICA ITALIANA SINTETICI SPACLOTRIMAZOLE

DMF 75481988

OLON SPACLOTRIMAZOLE

DMF 98061992

CORDEN PHARMA BERGAMO SPACLOTRIMAZOLE

DMF 107131994

AMOLI ORGANICS PVT LTDCLOTRIMAZOLE USP

DMF 264832012

SNJ LABS PVT LTDCLOTRIMAZOLE USP

DMF 359022021

SIFAVITOR SPAInactiveCLOTRIMAZOLE USP XX

DMF 54891984

MILES PHARMACEUTICAL DIV MILES INCInactiveCLOTRIMAZOLE 250 MG ORAL TABLETS

DMF 55571984

CUTTER BIOLOGICAL DIV MILES LABORATORIES INCInactiveCLOTRIMAZOLE

DMF 67291986

BAYER AGInactiveCLOTRIMAZOLE

DMF 67711987

SHANGHAI ZHONGXI SUNVE PHARMACEUTICAL CO LTDInactiveCLOTRIMAZOLE

DMF 197162006

JIANGSU YUNYANG GROUP PHARMACEUTICAL CO LTDInactiveCLOTRIMAZOLE

DMF 203972007

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 1%

0 patents0 exclusivities▴

CREAM;VAGINAL | Approved: Jul 16, 1993

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

ENCUBE replaced P AND L as the applicant for CLOTRIMAZOLE NDA 074165.

Old: P AND L

New: ENCUBE

MODIFIEDApplicant Full Name7/1/2026

ENCUBE Ethicals Private Ltd replaced P and L Development LLC as the applicant for Clotrimazole NDA 074165.

Old: P AND L DEVELOPMENT LLC

New: ENCUBE ETHICALS PRIVATE LTD