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Serving leading biopharmaceutical companies globally:

Argus Health
Julphar
Teva
Baxter
Healthtrust
Chubb
Colorcon
Boehringer Ingelheim
Johnson and Johnson
US Army

Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077298

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NDA 077298 describes METOPROLOL SUCCINATE, which is a drug marketed by Spil, Actavis Elizabeth, Actavis Labs Fl Inc, Dr Reddys Labs Ltd, Mylan Pharms Inc, Nesher Pharms, Novast Labs Ltd, Reddys, Sandoz, and Wockhardt, and is included in fourteen NDAs. It is available from thirty-nine 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-three suppliers are listed for this compound. Additional details are available on the metoprolol succinate profile page.
Summary for 077298
Tradename:METOPROLOL SUCCINATE
Applicant:Actavis Labs Fl Inc
Ingredient:metoprolol succinate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 077298
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 077298
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOPROLOL SUCCINATE metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 077298 ANDA Rebel Distributors Corp 21695-972 E 21695-972-30
METOPROLOL SUCCINATE metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 077298 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-795 N 43353-795-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 100MG TARTRATE
Approval Date:Apr 15, 2010TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 200MG TARTRATE
Approval Date:Apr 15, 2010TE:ABRLD:No

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