Details for New Drug Application (NDA): 078889
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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 078889
Tradename: | METOPROLOL SUCCINATE |
Applicant: | Reddys |
Ingredient: | metoprolol succinate |
Patents: | 0 |
Pharmacology for NDA: 078889
Mechanism of Action | Adrenergic beta-Antagonists |
Suppliers and Packaging for NDA: 078889
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
METOPROLOL SUCCINATE | metoprolol succinate | TABLET, EXTENDED RELEASE;ORAL | 078889 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7825 | 0615-7825-05 | 15 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7825-05) |
METOPROLOL SUCCINATE | metoprolol succinate | TABLET, EXTENDED RELEASE;ORAL | 078889 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7825 | 0615-7825-39 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (0615-7825-39) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 100MG TARTRATE | ||||
Approval Date: | Aug 15, 2012 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 200MG TARTRATE | ||||
Approval Date: | Aug 15, 2012 | TE: | AB | RLD: | No |
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