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PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

ANDA

CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | A200386 | COSETTE PHARMACEUTICALS NC LABORATORIES LLC

1 strength0 unique patents0 unique exclusivities

Products (1)

#001 — 10MG/5ML;6.25MG/5ML

0 patents0 exclusivities▴

SYRUP;ORAL | Approved: Jun 29, 2012

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

Cosette Pharmaceuticals updated its name to Cosette Pharms NC on the Orange Book entry for Promethazine Hydrochloride and Codeine Phosphate (NDA 200386).

Old: COSETTE

New: COSETTE PHARMS NC

MODIFIEDApplicant Full Name7/1/2026

Cosette Pharmaceuticals Inc changed its legal name to Cosette Pharmaceuticals NC Laboratories LLC for the NDA 200386 product (promethazine hydrochloride and codeine phosphate).

Old: COSETTE PHARMACEUTICALS INC

New: COSETTE PHARMACEUTICALS NC LABORATORIES LLC