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HYDROCORTISONE AND ACETIC ACID

ANDA

ACETIC ACID, GLACIAL; HYDROCORTISONE | A040609 | COSETTE PHARMACEUTICALS NC LABORATORIES LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: VOSOL HC(TE code: AT)

Products (1)

#001 — 2%;1%

0 patents0 exclusivities▴

SOLUTION/DROPS;OTIC | Approved: Feb 6, 2006

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Cosette Pharmaceuticals updated its legal entity name from "Cosette" to "Cosette Pharms NC" as the applicant for NDA 040609 (hydrocortisone and acetic acid).

Old: COSETTE

New: COSETTE PHARMS NC

MODIFIEDApplicant Full Name7/1/2026

Cosette Pharmaceuticals updated its legal entity name from Cosette Pharmaceuticals Inc to Cosette Pharmaceuticals NC Laboratories LLC for the hydrocortisone and acetic acid otic solution (NDA 040609).

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC