You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 4, 2024

Details for New Drug Application (NDA): 078889


✉ Email this page to a colleague

« Back to Dashboard


NDA 078889 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, Lupin, Mylan Pharms Inc, Nesher Pharms, Novast Labs, Pharmadax Inc, Prinston Inc, Reddys, Sandoz, Sunshine, Visum Pharm, Wockhardt, Yichang Humanwell, Zhejiang Jutai Pharm, and Zydus Pharms, and is included in twenty-seven NDAs. It is available from forty-three 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-eight suppliers are listed for this compound. Additional details are available on the metoprolol succinate profile page.
Summary for 078889
Tradename:METOPROLOL SUCCINATE
Applicant:Reddys
Ingredient:metoprolol succinate
Patents:0
Pharmacology for NDA: 078889
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 078889
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOPROLOL SUCCINATE metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 078889 ANDA NCS HealthCare of KY, LLC dba Vangard Labs 0615-7825 0615-7825-05 15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7825-05)
METOPROLOL SUCCINATE metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 078889 ANDA NCS HealthCare of KY, LLC dba Vangard Labs 0615-7825 0615-7825-39 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7825-39)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 100MG TARTRATE
Approval Date:Aug 15, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 200MG TARTRATE
Approval Date:Aug 15, 2012TE:ABRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.