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PRO-BANTHINE

NDA

PROPANTHELINE BROMIDE | N008732 | SHIRE DEVELOPMENT INC

2 strengths0 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 Chain0 active DMFs5 inactive

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

GANES CHEMICALS INC PENNSVILLE DIVInactivePROPANTHELINE BROMIDE

DMF 23211974

ERCOPHARMInactivePROPANTHELINE BROMIDE

DMF 36031979

HEXAGON LABORATORIES INCInactivePROPANTHELINE BROMIDE

DMF 64691986

CHEMWERTH INCInactivePROPANTHELINE BROMIDE

DMF 76911988

TOKUYAMA CORPInactivePROPANTHELINE BROMIDE

DMF 171402004

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

Products (2)

Sort:

#002 — 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#003 — 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982