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CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE

ANDA

BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE | A210765 | COSETTE PHARMACEUTICALS NC LABORATORIES LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: TACLONEX(TE code: AB)

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 4, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.064%;0.005%

0 patents0 exclusivities▴

SUSPENSION;TOPICAL | Approved: May 11, 2020

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant Full Name7/1/2026

Cosette Pharmaceuticals Inc changed its legal entity name to Cosette Pharmaceuticals NC Laboratories LLC for NDA 210765 (calcipotriene and betamethasone dipropionate).

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC

MODIFIEDApplicant7/1/2026

Cosette Pharmaceuticals expanded its legal entity name from "Cosette" to "Cosette Pharms NC" for the calcipotriene and betamethasone dipropionate combination product (NDA 210765).

Old: COSETTE

New: COSETTE PHARMS NC