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Generated: May 23, 2017

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Details for New Drug Application (NDA): 090617

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NDA 090617 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-eight 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. Forty suppliers are listed for this compound. Additional details are available on the metoprolol succinate profile page.

Summary for NDA: 090617

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

Pharmacology for NDA: 090617

Mechanism of ActionAdrenergic beta-Antagonists

Suppliers and Packaging for NDA: 090617

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOPROLOL SUCCINATE
metoprolol succinate
TABLET, EXTENDED RELEASE;ORAL 090617 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7823 0615-7823-05 15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7823-05)
METOPROLOL SUCCINATE
metoprolol succinate
TABLET, EXTENDED RELEASE;ORAL 090617 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-7823 0615-7823-30 6 BLISTER PACK in 1 BOX, UNIT-DOSE (0615-7823-30) > 5 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 25MG TARTRATE
Approval Date:Aug 1, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 50MG TARTRATE
Approval Date:Aug 1, 2012TE:ABRLD: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.

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