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URECHOLINE

NDA

BETHANECHOL CHLORIDE | N006536 | TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC

5 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 Chain3 active DMFs4 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

SIEGFRIED EVIONNAZ SABETHANECHOL CHLORIDE

DMF 157372001

SERATEC SASBETHANECHOL CHLORIDE USP

DMF 158662002

WOCKHARDT LTDBETHANECHOL CHLORIDE USP

DMF 161192002

GANES CHEMICALS INC PENNSVILLE DIVInactiveBETHANECHOL CHLORIDE

DMF 25011975

GANES CHEMICALS INC PENNSVILLE DIVInactiveBETHANECHOL CHLORIDE

DMF 43481981

CK FINE CHEMICALS INCInactiveBETHANECHOL CHLORIDE

DMF 47661982

CORDEN PHARMA BERGAMO SPAInactiveBETHANECHOL CHLORIDE

DMF 152132000

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

Products (5)

Sort:

#001 — 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

#003 — 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

#004 — 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

#005 — 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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