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ACTIDIL

NDA

TRIPROLIDINE HYDROCHLORIDE | N011496 | GLAXOSMITHKLINE

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 Chain2 active DMFs5 inactive

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

MALLADI DRUGS AND PHARMACEUTICALS LTDTRIPROLIDINE HYDROCHLORIDE

DMF 179022004

HIKAL LTDTRIPROLIDINE HYDROCHLORIDE USP

DMF 190192005

REDEVAN LABS INCInactiveTRIPROLIDINE HYDROCHLORIDE

DMF 25121975

H REISMAN CORPInactiveTRIPROLIDINE HYDROCHLORIDE

DMF 52871984

SUMIKA FINE CHEMICALS CO LTDInactiveTRIPROLIDINE HYDROCHLORIDE

DMF 89471991

LONZA INCInactiveTRIPROLIDINE HYDROCHLORIDE

DMF 106481993

LONZA INCInactiveTRIPROLIDINE HYDROCHLORIDE

DMF 178872004

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

Products (1)

#002 — 1.25MG/5ML

0 patents0 exclusivities▴

SYRUP;ORAL | Approved: Jul 1, 1983

No patent or exclusivity listings for this strength.