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Generated: September 25, 2018

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Details for New Drug Application (NDA): 076862

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NDA 076862 describes METOPROLOL SUCCINATE, which is a drug marketed by Actavis Elizabeth, Actavis Labs Fl Inc, Dr Reddys Labs Ltd, Mylan Pharms Inc, Nesher Pharms, Novast Labs Ltd, Reddys, Sandoz, Wockhardt, and Zydus Pharms Usa Inc, and is included in thirteen NDAs. It is available from forty-one suppliers. Additional details are available on the METOPROLOL SUCCINATE profile page.

The generic ingredient in METOPROLOL SUCCINATE is metoprolol succinate. There are fifty-nine 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 076862
Tradename:METOPROLOL SUCCINATE
Applicant:Actavis Labs Fl Inc
Ingredient:metoprolol succinate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076862
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 076862
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOPROLOL SUCCINATE metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 076862 ANDA Rebel Distributors Corp 21695-950 21695-950-30 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (21695-950-30)
METOPROLOL SUCCINATE metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 076862 ANDA Rebel Distributors Corp 21695-950 21695-950-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (21695-950-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 50MG TARTRATE
Approval Date:Aug 3, 2009TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 25MG TARTRATE
Approval Date:Aug 3, 2009TE:ABRLD:No

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