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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 073609

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NDA 073609 describes PINDOLOL, which is a drug marketed by Ani Pharms, Aurobindo Pharma Usa, Cosette, Mpp Pharma, Mylan Pharms Inc, Nostrum Labs, Purepac Pharm, Sun Pharm Industries, Unichem, Watson Labs, and Zydus Pharms, and is included in fourteen NDAs. It is available from eight suppliers. Additional details are available on the PINDOLOL profile page.

The generic ingredient in PINDOLOL is pindolol. There are eleven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the pindolol profile page.

Summary for 073609

Tradename:	PINDOLOL
Applicant:	Ani Pharms
Ingredient:	pindolol
Patents:	0

Pharmacology for NDA: 073609

Mechanism of Action	Adrenergic beta-Antagonists

Medical Subject Heading (MeSH) Categories for 073609

Adrenergic beta-Antagonists
Antihypertensive Agents
Serotonin Antagonists
Vasodilator Agents

Suppliers and Packaging for NDA: 073609

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PINDOLOL	pindolol	TABLET;ORAL	073609	ANDA	Marlex Pharmaceuticals, Inc.	10135-743	10135-743-01	100 TABLET in 1 BOTTLE (10135-743-01)
PINDOLOL	pindolol	TABLET;ORAL	073609	ANDA	Marlex Pharmaceuticals, Inc.	10135-744	10135-744-01	100 TABLET in 1 BOTTLE (10135-744-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Mar 29, 1993	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Mar 29, 1993	TE:	AB	RLD:	No

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