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Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077176

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NDA 077176 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 077176
Applicant:Nesher Pharms
Ingredient:metoprolol succinate
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 077176
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 077176
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOPROLOL SUCCINATE metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 077176 ANDA Ethex Corporation 58177-293 E 58177-293-12
METOPROLOL SUCCINATE metoprolol succinate TABLET, EXTENDED RELEASE;ORAL 077176 ANDA Ethex Corporation 58177-293 E 58177-293-09

Profile for product number 001

Approval Date:May 14, 2008TE:RLD:No

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