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BUTISOL SODIUM

NDA

BUTABARBITAL SODIUM | N000793 | PHARMOBEDIENT CONSULTING LLC

4 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 Chain1 active DMF4 inactive

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

CHATTEM CHEMICALS INCBUTABARBITAL SODIUM

DMF 144381999

GANES CHEMICALS INC PENNSVILLE DIVInactiveBUTABARBITAL

DMF 10481967

GRINDSTED PRODUCTSInactiveBUTABARBITAL SODIUM

DMF 43661981

DANISCO INGREDIENTSInactiveBUTABARBITAL

DMF 64901986

CHEMISCHE FABRIK BERG GMBHInactiveBUTABARBITAL SODIUM

DMF 147912000

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Feb 14, 2019	SUPPL -26	View Letter (PDF)
Oct 4, 2007	SUPPL -25	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#002 — 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#003 — 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

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

#004 — 30MG

RLD

0 patents0 exclusivities▾

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

#005 — 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

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