DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 090615
NDA 090615 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, Wockhardt, and Zydus Pharms Usa Inc, and is included in fourteen NDAs. It is available from forty suppliers. There are two patents protecting this drug. 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-four suppliers are listed for this compound. 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-four suppliers are listed for this compound. Additional details are available on the metoprolol succinate profile page.
Summary for 090615
| Tradename: | METOPROLOL SUCCINATE |
| Applicant: | Wockhardt |
| Ingredient: | metoprolol succinate |
| Patents: | 0 |
| Therapeutic Class: | Cardiovascular Agents |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090615
| Mechanism of Action | Adrenergic beta-Antagonists |
Suppliers and Packaging for NDA: 090615
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METOPROLOL SUCCINATE | metoprolol succinate | TABLET, EXTENDED RELEASE;ORAL | 090615 | ANDA | NCS HealthCare of KY, Inc dba Vangard Labs | 0615-6589 | N | 0615-6589-39 |
| METOPROLOL SUCCINATE | metoprolol succinate | TABLET, EXTENDED RELEASE;ORAL | 090615 | ANDA | NCS HealthCare of KY, Inc dba Vangard Labs | 0615-6597 | N | 0615-6597-39 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 25MG TARTRATE | ||||
| Approval Date: | Jul 22, 2010 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 50MG TARTRATE | ||||
| Approval Date: | Jul 22, 2010 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 100MG TARTRATE | ||||
| Approval Date: | Jul 22, 2010 | TE: | AB | RLD: | No | ||||
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