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PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE

ANDA

DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE | A091687 | COSETTE PHARMACEUTICALS NC LABORATORIES LLC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE(TE code: AA)

Products (1)

#001 — 15MG/5ML;6.25MG/5ML

0 patents0 exclusivities▴

SYRUP;ORAL | Approved: Jun 28, 2012

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Cosette Pharmaceuticals updated the applicant name for the promethazine hydrochloride and dextromethorphan hydrobromide combination (NDA 091687) from "Cosette" to "Cosette Pharms NC" in the FDA Orange Book.

Old: COSETTE

New: COSETTE PHARMS NC

MODIFIEDApplicant Full Name7/1/2026

Cosette Pharmaceuticals Inc changed its legal entity name to Cosette Pharmaceuticals NC Laboratories LLC for the promethazine hydrochloride and dextromethorphan hydrobromide combination product (NDA 091687).

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC