Details for New Drug Application (NDA): 210428
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The generic ingredient in KAPSPARGO SPRINKLE 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 210428
Tradename: | KAPSPARGO SPRINKLE |
Applicant: | Spil |
Ingredient: | metoprolol succinate |
Patents: | 2 |
Pharmacology for NDA: 210428
Mechanism of Action | Adrenergic beta-Antagonists |
Suppliers and Packaging for NDA: 210428
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
KAPSPARGO SPRINKLE | metoprolol succinate | CAPSULE, EXTENDED RELEASE;ORAL | 210428 | NDA | Sun Pharmaceutical Industries, Inc. | 10631-008 | 10631-008-30 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10631-008-30) |
KAPSPARGO SPRINKLE | metoprolol succinate | CAPSULE, EXTENDED RELEASE;ORAL | 210428 | NDA | Sun Pharmaceutical Industries, Inc. | 10631-009 | 10631-009-30 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10631-009-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | EQ 25MG TARTRATE | ||||
Approval Date: | Jan 26, 2018 | TE: | RLD: | Yes | |||||
Patent: | 9,504,655 | Patent Expiration: | Jul 9, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | 9,700,530 | Patent Expiration: | Jul 9, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | EQ 50MG TARTRATE | ||||
Approval Date: | Jan 26, 2018 | TE: | RLD: | Yes | |||||
Patent: | 9,504,655 | Patent Expiration: | Jul 9, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? |
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