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PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE

ANDA

CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE | A040660 | PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC AND DBA PAI PHARMA

1 strength0 unique patents0 unique exclusivities

Products (1)

#001 — 10MG/5ML;5MG/5ML;6.25MG/5ML

0 patents0 exclusivities▴

SYRUP;ORAL | Approved: Dec 7, 2006

No patent or exclusivity listings for this strength.

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant7/1/2026

PAI Holdings replaced Genus Lifesciences as the applicant for Promethazine Hydrochloride, Phenylephrine Hydrochloride, and Codeine Phosphate (NDA 040660).

Old: GENUS LIFESCIENCES

New: PAI HOLDINGS

MODIFIEDApplicant Full Name7/1/2026

PAI Holdings LLC acquired NDA 040660 for Promethazine Hydrochloride, Phenylephrine Hydrochloride, and Codeine Phosphate from Genus Life Sciences Inc.

Old: GENUS LIFE SCIENCES INC

New: PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC AND DBA PAI PHARMA