Details for New Drug Application (NDA): 212516
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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: | ⤷ Sign Up | Patent Expiration: | Apr 13, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 13, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Apr 13, 2037 | Product Flag? | Y | Substance Flag? | Delist Request? |
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