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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 205415

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NDA 205415 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 205415

Tradename:	PINDOLOL
Applicant:	Mpp Pharma
Ingredient:	pindolol
Patents:	0

Pharmacology for NDA: 205415

Mechanism of Action	Adrenergic beta-Antagonists

Medical Subject Heading (MeSH) Categories for 205415

Adrenergic beta-Antagonists
Antihypertensive Agents
Serotonin Antagonists
Vasodilator Agents

Suppliers and Packaging for NDA: 205415

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PINDOLOL	pindolol	TABLET;ORAL	205415	ANDA	Nostrum Laboratories, Inc.	29033-028	29033-028-01	100 TABLET in 1 BOTTLE (29033-028-01)
PINDOLOL	pindolol	TABLET;ORAL	205415	ANDA	Nostrum Laboratories, Inc.	29033-029	29033-029-01	100 TABLET in 1 BOTTLE (29033-029-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Jan 13, 2016	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Jan 13, 2016	TE:	AB	RLD:	No

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