CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE | N008306 | ANI PHARMACEUTICALS INC
2 strengths0 unique patents0 unique exclusivities
PTAB Proceedings
No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board
Hatch-Waxman Litigation
No ANDA patent litigation cases (NOS 835) matched from PACER
Citizen Petitions
No FDA citizen petitions matched from Regulations.gov
Products (2)
Sort:
#005 — 10MG/5ML;5MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
RLD
0 patents0 exclusivities▾
SYRUP;ORAL | Approved: Apr 2, 1984
#004 — 10MG/5ML;6.25MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
RLD
0 patents0 exclusivities▴
SYRUP;ORAL | Approved: Apr 2, 1984
No patent or exclusivity listings for this strength.