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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 206980

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NDA 206980 describes METOPROLOL SUCCINATE, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Actavis Labs Fl Inc, Alkem Labs Ltd, Cipla, Dr Reddys Labs Ltd, Granules, Hetero Labs Ltd Iii, Ipca Labs Ltd, Lupin, Mylan Pharms Inc, Nesher Pharms, Novast Labs, Pharmadax Inc, Prinston Inc, Reddys, Sandoz, Sunshine, Visum Pharm, Wockhardt Bio Ag, Yichang Humanwell, Zhejiang Jutai Pharm, and Zydus Pharms, and is included in twenty-eight NDAs. It is available from forty-four suppliers. Additional details are available on the METOPROLOL SUCCINATE profile page.

The generic ingredient in METOPROLOL SUCCINATE is metoprolol succinate. There are sixty drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the metoprolol succinate profile page.

Summary for 206980

Tradename:	METOPROLOL SUCCINATE
Applicant:	Ipca Labs Ltd
Ingredient:	metoprolol succinate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 25MG TARTRATE
Approval Date:	Jun 25, 2025	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 50MG TARTRATE
Approval Date:	Jun 25, 2025	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 100MG TARTRATE
Approval Date:	Jun 25, 2025	TE:	AB	RLD:	No

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