Details for New Drug Application (NDA): 090617
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NDA 090617 describes METOPROLOL SUCCINATE, which is a drug marketed by Accord Hlthcare, Actavis Elizabeth, Actavis Labs Fl Inc, Alkem Labs Ltd, Cipla, Dr Reddys Labs Ltd, Granules, Hetero Labs Ltd Iii, Ipca Labs Ltd, Lupin, Mylan Pharms Inc, Nesher Pharms, Novast Labs, Pharmadax, Prinston Inc, Reddys, Sandoz, Sunshine, Visum Pharm, Wockhardt Bio Ag, Yichang Humanwell, Zhejiang Jutai Pharm, and Zydus Pharms, and is included in twenty-eight NDAs. It is available from forty-four suppliers. Additional details are available on the METOPROLOL SUCCINATE profile page.
The generic ingredient in METOPROLOL SUCCINATE is metoprolol succinate. There are sixty drug master file entries for this compound. Forty-seven 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 sixty drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the metoprolol succinate profile page.
Summary for 090617
| Tradename: | METOPROLOL SUCCINATE |
| Applicant: | Dr Reddys Labs Ltd |
| Ingredient: | metoprolol succinate |
| Patents: | 0 |
Pharmacology for NDA: 090617
| Mechanism of Action | Adrenergic beta-Antagonists |
Suppliers and Packaging for NDA: 090617
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METOPROLOL SUCCINATE | metoprolol succinate | TABLET, EXTENDED RELEASE;ORAL | 090617 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7823 | 0615-7823-05 | 15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7823-05) |
| METOPROLOL SUCCINATE | metoprolol succinate | TABLET, EXTENDED RELEASE;ORAL | 090617 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7823 | 0615-7823-28 | 28 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7823-28) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 25MG TARTRATE | ||||
| Approval Date: | Aug 1, 2012 | 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: | Aug 1, 2012 | TE: | AB | RLD: | No | ||||
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