Viewing data from:

CODEINE SULFATE

NDA

CODEINE SULFATE | N202245 | HIKMA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF3 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

SPECGX LLCCODEINE SULFATE USP POWDER

DMF 211172007

MALLINCKRODT INCInactiveCODEINE SULFATE

DMF 52331984

PENICK CORPInactiveCODEINE SULFATE

DMF 93681991

NORAMCO DELAWARE INCInactiveCODEINE SULFATE

DMF 101591993

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

13 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 30MG/5ML

0 patents0 exclusivities▴

SOLUTION;ORAL | Approved: Jun 30, 2011

No patent or exclusivity listings for this strength.