Details for New Drug Application (NDA): 203028
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NDA 203028 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 Inc, 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 203028
| Tradename: | METOPROLOL SUCCINATE |
| Applicant: | Pharmadax Inc |
| Ingredient: | metoprolol succinate |
| Patents: | 0 |
Pharmacology for NDA: 203028
| Mechanism of Action | Adrenergic beta-Antagonists |
Suppliers and Packaging for NDA: 203028
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| METOPROLOL SUCCINATE | metoprolol succinate | TABLET, EXTENDED RELEASE;ORAL | 203028 | ANDA | Nivagen Pharmaceuticals, Inc. | 75834-290 | 75834-290-00 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (75834-290-00) |
| METOPROLOL SUCCINATE | metoprolol succinate | TABLET, EXTENDED RELEASE;ORAL | 203028 | ANDA | Nivagen Pharmaceuticals, Inc. | 75834-290 | 75834-290-01 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (75834-290-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 25MG TARTRATE | ||||
| Approval Date: | Mar 31, 2020 | 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: | Mar 31, 2020 | TE: | AB | RLD: | No | ||||
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