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PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE

ANDA

PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE | A040654 | PAI HOLDINGS LLC DBA PHARMACEUTICAL ASSOCIATES INC AND DBA PAI PHARMA

1 strength0 unique patents0 unique exclusivities

Products (1)

#001 — 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 became the applicant for NDA 040654 (Phenylephrine Hydrochloride and Promethazine Hydrochloride), replacing Genus.

Old: GENUS

New: PAI HOLDINGS

MODIFIEDApplicant Full Name7/1/2026

PAI Holdings LLC (doing business as Pharmaceutical Associates Inc and PAI Pharma) replaced Genus Lifesciences Inc as the applicant for phenylephrine hydrochloride and promethazine hydrochloride (NDA 040654).

Old: GENUS LIFESCIENCES INC

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