Kapspargo Sprinkle

Lowers the risk of cardiovascular mortality and heart-failure hospitalization. NDA 210428, held by Spil. Metoprolol Succinate.

As of Nov 13, 2026, NDA 210428 (Kapspargo Sprinkle), held by Spil, was first approved by FDA on Jan 26, 2018, with 2 approved supplements and 0 published complete response letters.

First approved: Jan 26, 2018
Review: Standard
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Metoprolol succinate extended-release capsules are beta 1 -selective adrenoceptor blocking agent indicated for the treatment of:

Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions.
Angina Pectoris.
Heart Failure, to reduce the risk of cardiovascular mortality and heart-failure hospitalization in patients with heart failure. 1.1 Hypertension Metoprolol succinate extended-release capsules are indicated for the treatment of hypertension, to lower blood pressure.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jan 26, 2018	Original applicationNew dosage form · Standard review	Approved	Review Label Letter Pediatric CDTL Review

Products

4 strengths and forms

Product	Active ingredient	Marketing
Kapspargo SprinkleEQ 25MG TARTRATE · capsule, extended release;oral	Metoprolol Succinate	RxReference drug
Kapspargo SprinkleEQ 50MG TARTRATE · capsule, extended release;oral	Metoprolol Succinate	RxReference drug
Kapspargo SprinkleEQ 100MG TARTRATE · capsule, extended release;oral	Metoprolol Succinate	RxReference drug
Kapspargo SprinkleEQ 200MG TARTRATE · capsule, extended release;oral	Metoprolol Succinate	RxReference drug

All 3 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Apr 14, 2023	Supplement 6Labeling · Standard review	Approved	Label Letter
May 14, 2018	Supplement 1Labeling · Standard review	Approved	Label
Jan 26, 2018	Original applicationNew dosage form · Standard review	Approved	Review Label Letter Pediatric CDTL Review

Identifiers

Application: NDA 210428
Drugs@FDA: Overview at FDA
Company: SPIL

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters