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Details for New Drug Application (NDA): 076640

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NDA 076640 describes METOPROLOL SUCCINATE, which is a drug marketed by Wockhardt, Dr Reddys Labs Ltd, Actavis Labs Fl Inc, Mylan Pharms Inc, Nesher Pharms, Sandoz, and Reddys, and is included in eleven NDAs. It is available from thirty-seven suppliers. Additional details are available on the METOPROLOL SUCCINATE profile page.

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

Summary for NDA: 076640

Tradename:
METOPROLOL SUCCINATE
Applicant:
Nesher Pharms
Ingredient:
metoprolol succinate
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 076640

Mechanism of ActionAdrenergic beta-Antagonists

Suppliers and Packaging for NDA: 076640

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
METOPROLOL SUCCINATE
metoprolol succinate
TABLET, EXTENDED RELEASE;ORAL 076640 ANDA Ethex Corporation 58177-358 58177-358-04 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58177-358-04)
METOPROLOL SUCCINATE
metoprolol succinate
TABLET, EXTENDED RELEASE;ORAL 076640 ANDA Ethex Corporation 58177-358 58177-358-09 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58177-358-09)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 200MG TARTRATE
Approval Date:May 18, 2007TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 100MG TARTRATE
Approval Date:May 18, 2007TE:RLD:No


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