Details for New Drug Application (NDA): 090694
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The generic ingredient in DULOXETINE HYDROCHLORIDE is duloxetine hydrochloride. There are forty-two drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the duloxetine hydrochloride profile page.
Summary for 090694
Tradename: | DULOXETINE HYDROCHLORIDE |
Applicant: | Lupin Ltd |
Ingredient: | duloxetine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 090694
Mechanism of Action | Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 090694
Suppliers and Packaging for NDA: 090694
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DULOXETINE HYDROCHLORIDE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 090694 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8494 | 0615-8494-39 | 30 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8494-39) |
DULOXETINE HYDROCHLORIDE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 090694 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8495 | 0615-8495-05 | 15 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (0615-8495-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Dec 11, 2013 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 30MG BASE | ||||
Approval Date: | Dec 11, 2013 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 40MG BASE | ||||
Approval Date: | Dec 11, 2013 | TE: | AB | RLD: | No |
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