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. Forty-nine suppliers are listed for this compound. Additional details are available on the metoprolol succinate profile page.
The generic ingredient in KAPSPARGO SPRINKLE is metoprolol succinate. There are sixty drug master file entries for this compound. Forty-nine 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: | ⤷ Sign Up | Patent Expiration: | Jul 9, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | 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: | ⤷ Sign Up | Patent Expiration: | Jul 9, 2035 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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