Last Updated: November 8, 2026

Details for New Drug Application (NDA): 074063

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NDA 074063 describes PINDOLOL, which is a drug marketed by Ani Pharms, Aurobindo Pharma Usa, Cosette Pharms Nc, 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 is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the pindolol profile page.

Summary for 074063

Tradename:	PINDOLOL
Applicant:	Sun Pharm Industries
Ingredient:	pindolol
Patents:	0

Pharmacology for NDA: 074063

Mechanism of Action	Adrenergic beta-Antagonists

Medical Subject Heading (MeSH) Categories for 074063

Adrenergic beta-Antagonists
Antihypertensive Agents
Serotonin Antagonists
Vasodilator Agents

Suppliers and Packaging for NDA: 074063

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PINDOLOL	pindolol	TABLET;ORAL	074063	ANDA	Sun Pharmaceutical Industries, Inc.	57664-655	57664-655-88	100 TABLET in 1 BOTTLE, PLASTIC (57664-655-88)
PINDOLOL	pindolol	TABLET;ORAL	074063	ANDA	PD-Rx Pharmaceuticals, Inc.	72789-293	72789-293-01	100 TABLET in 1 BOTTLE, PLASTIC (72789-293-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Jan 27, 1994	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Jan 27, 1994	TE:	AB	RLD:	No

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