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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 203894


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NDA 203894 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, and Zydus Pharms, and is included in twenty-six 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-nine suppliers are listed for this compound. Additional details are available on the metoprolol succinate profile page.
Summary for 203894
Tradename:METOPROLOL SUCCINATE
Applicant:Zydus Pharms
Ingredient:metoprolol succinate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203894
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 203894
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOPROLOL SUCCINATE metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 203894 ANDA Northstar Rx LLC 16714-852 16714-852-01 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-852-01)
METOPROLOL SUCCINATE metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 203894 ANDA Northstar Rx LLC 16714-852 16714-852-02 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-852-02)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 25MG TARTRATE
Approval Date:Mar 23, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 50MG TARTRATE
Approval Date:Mar 23, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 100MG TARTRATE
Approval Date:Mar 23, 2018TE:ABRLD:No

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