Details for New Drug Application (NDA): 203028
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The generic ingredient in METOPROLOL SUCCINATE is metoprolol succinate. There are sixty drug master file entries for this compound. Forty-nine 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 |
Formulation / Manufacturing: | see details |
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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