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NDA

PINDOLOL | N018285 | NOVARTIS PHARMACEUTICALS CORP

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

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Psilocybin Administration With 5-HT1a Blockade NCT07565493	Early Phase 1	Recruiting	Johns Hopkins University	18	2026-08-01 → 2028-06-15

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain2 active DMFs7 inactive

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

PCASPINDOLOL

DMF 71881987

CENTAUR PHARMACEUTICALS PRIVATE LTDPINDOLOL USP

DMF 316222017

ELAN CORP PLCInactivePINDOLOL

DMF 63131986

INDUSTRIE CHIMICHE FARMACEUTICHE ITALIANE SPAInactivePINDOLOL

DMF 66611986

KATSURA CHEMICAL CO LTDInactivePINDOLOL

DMF 77941988

DAITO CORPInactivePINDOLOL

DMF 78721989

LUSOCHIMICA SPAInactivePINDOLOL

DMF 85471990

DAISO CO LTDInactivePINDOLOL

DMF 85851990

ACE JAPAN CO LTDInactivePINDOLOL

DMF 159632002

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 8, 2007	SUPPL -34	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Sep 3, 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#002 — 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: Sep 3, 1982