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Generated: September 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 090615

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NDA 090615 describes METOPROLOL SUCCINATE, which is a drug marketed by Wockhardt, Dr Reddys Labs Ltd, Actavis Labs Fl Inc, Mylan Pharms Inc, Nesher Pharms, Actavis Elizabeth, Sandoz, and Reddys, and is included in twelve NDAs. It is available from thirty-seven suppliers. Additional details are available on the METOPROLOL SUCCINATE profile page.

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

Summary for NDA: 090615

Tradename:	1
Applicant:	1
Ingredient:	1
Patents:	0
Therapeutic Class:	Cardiovascular Agents
Formulation / Manufacturing:	see details

Pharmacology for NDA: 090615

Mechanism of Action	Adrenergic beta-Antagonists

Suppliers and Packaging for NDA: 090615

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
METOPROLOL SUCCINATE	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	090615	ANDA	NCS HealthCare of KY, Inc dba Vangard Labs	0615-6589	0615-6589-39	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0615-6589-39)
METOPROLOL SUCCINATE	metoprolol succinate	TABLET, EXTENDED RELEASE;ORAL	090615	ANDA	NCS HealthCare of KY, Inc dba Vangard Labs	0615-6597	0615-6597-39	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (0615-6597-39)

Summary for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 25MG TARTRATE
Approval Date:	Jul 22, 2010	TE:	AB	RLD:	No

Summary for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 50MG TARTRATE
Approval Date:	Jul 22, 2010	TE:	AB	RLD:	No

Summary for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, EXTENDED RELEASE;ORAL			Strength	EQ 100MG TARTRATE
Approval Date:	Jul 22, 2010	TE:	AB	RLD:	No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.