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CALCIPOTRIENE

ANDA

CALCIPOTRIENE | A078468 | COSETTE PHARMACEUTICALS NC LABORATORIES LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain9 active DMFs4 inactive

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

LEO PHARMA ASCALCIPOTRIENE HYDRATE DRUG SUBSTANCE

DMF 105141993

LEO PHARMA ASCALCIPOTRIENE CREAM

DMF 105151993

TAPI NL BVCALCIPOTRIENE USP

DMF 169582003

ALP PHARM BEIJING CO LTDCALCIPOTRIENE (CALCIPOTRIOL)

DMF 219432008

CERBIOS PHARMA SACALCIPOTRIENE ANHYDROUS

DMF 231032009

ALP PHARM BEIJING CO LTDCALCIPOTRIENE HYDRATE

DMF 272222013

CERBIOS PHARMA SACALCIPOTRIENE MONOHYDRATE

DMF 306152016

NANJING HERON PHARMACEUTICAL CO LTDCALCIPOTRIENE MONOHYDRATE

DMF 387432023

ANHUI HAOYUAN PHARMACEUTICAL CO LTDCALCIPOTRIENE

DMF 406922024

LEO PHARMA ASInactiveCALCIPOTRIENE DRUG SUBSTANCE

DMF 83081989

LEO PHARMA ASInactiveCALCIPOTRIENE OINTMENT

DMF 83121989

LEO PHARMA ASInactiveCALCIPOTRIENE SCALP SOLUTION

DMF 108391994

SAFC INCInactiveCALCIPOTRIENE

DMF 169282003

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

Products (1)

#001 — 0.005%

0 patents0 exclusivities▴

SOLUTION;TOPICAL | Approved: Mar 24, 2011

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

COSETTE Pharmaceuticals NC acquired ownership of the calcipotriene NDA 078468, replacing COSETTE as the applicant of record.

Old: COSETTE

New: COSETTE PHARMS NC

MODIFIEDApplicant Full Name7/1/2026

Cosette Pharmaceuticals changed its legal entity name to Cosette Pharmaceuticals NC Laboratories LLC for the calcipotriene NDA 078468.

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC