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Generated: April 26, 2019

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Details for New Drug Application (NDA): 210428

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NDA 210428 describes KAPSPARGO SPRINKLE, which is a drug marketed by Spil and is included in one NDA. It is available from two suppliers. There are two patents protecting this drug. Additional details are available on the KAPSPARGO SPRINKLE profile page.

The generic ingredient in KAPSPARGO SPRINKLE is metoprolol succinate. There are sixty drug master file entries for this compound. Fifty 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 210428
Mechanism of ActionAdrenergic 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:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 25MG TARTRATE
Approval Date:Jan 26, 2018TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jul 9, 2035Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Jul 9, 2035Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrengthEQ 50MG TARTRATE
Approval Date:Jan 26, 2018TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jul 9, 2035Product Flag?YSubstance Flag?Delist Request?

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