Details for New Drug Application (NDA): 212516
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NDA 212516 describes DRIZALMA SPRINKLE, which is a drug marketed by Sun Pharm and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the DRIZALMA SPRINKLE profile page.
The generic ingredient in DRIZALMA SPRINKLE is duloxetine hydrochloride. There are forty-two drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the duloxetine hydrochloride profile page.
The generic ingredient in DRIZALMA SPRINKLE is duloxetine hydrochloride. There are forty-two drug master file entries for this compound. Fifty suppliers are listed for this compound. Additional details are available on the duloxetine hydrochloride profile page.
Summary for 212516
| Tradename: | DRIZALMA SPRINKLE |
| Applicant: | Sun Pharm |
| Ingredient: | duloxetine hydrochloride |
| Patents: | 4 |
Pharmacology for NDA: 212516
| Mechanism of Action | Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 212516
Suppliers and Packaging for NDA: 212516
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DRIZALMA SPRINKLE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 212516 | NDA | SUN PHARMACEUTICAL INDUSTRIES, INC. | 47335-616 | 47335-616-10 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-616-10) |
| DRIZALMA SPRINKLE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 212516 | NDA | SUN PHARMACEUTICAL INDUSTRIES, INC. | 47335-616 | 47335-616-30 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (47335-616-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Jul 19, 2019 | TE: | RLD: | Yes | |||||
| Patent: | 10,413,525 | Patent Expiration: | Apr 13, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 10,959,982 | Patent Expiration: | Apr 13, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 11,202,772 | Patent Expiration: | Apr 13, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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