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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 Wockhardt, Dr Reddys Labs Ltd, Actavis Labs Fl Inc, Mylan Pharms Inc, Nesher Pharms, Actavis Elizabeth, Sandoz, and Reddys, and is included in twelve NDAs. It is available from thirty-eight suppliers. Additional details are available on the METOPROLOL SUCCINATE profile page.

The generic ingredient in METOPROLOL SUCCINATE is metoprolol succinate. There are fifty-seven drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the metoprolol succinate profile page.

Summary for NDA: 076862

Actavis Labs Fl Inc
metoprolol succinate
Therapeutic Class:Cardiovascular Agents
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
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
TABLET, EXTENDED RELEASE;ORAL 076862 ANDA Rebel Distributors Corp 21695-950 21695-950-90 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (21695-950-90)

Summary for product number 001

Approval Date:Aug 3, 2009TE:ABRLD:No

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