Details for New Drug Application (NDA): 216509
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The generic ingredient in METOPROLOL SUCCINATE is metoprolol succinate. There are sixty drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the metoprolol succinate profile page.
Summary for 216509
Tradename: | METOPROLOL SUCCINATE |
Applicant: | Granules |
Ingredient: | metoprolol succinate |
Patents: | 0 |
Pharmacology for NDA: 216509
Mechanism of Action | Adrenergic beta-Antagonists |
Suppliers and Packaging for NDA: 216509
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METOPROLOL SUCCINATE | metoprolol succinate | TABLET, EXTENDED RELEASE;ORAL | 216509 | ANDA | Granules India Ltd | 62207-130 | 62207-130-49 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62207-130-49) |
METOPROLOL SUCCINATE | metoprolol succinate | TABLET, EXTENDED RELEASE;ORAL | 216509 | ANDA | Granules India Ltd | 62207-130 | 62207-130-54 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (62207-130-54) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 25MG TARTRATE | ||||
Approval Date: | Aug 7, 2023 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 50MG TARTRATE | ||||
Approval Date: | Aug 7, 2023 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 100MG TARTRATE | ||||
Approval Date: | Aug 7, 2023 | TE: | RLD: | No |
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