Details for New Drug Application (NDA): 203088
✉ Email this page to a colleague
The generic ingredient in DULOXETINE HYDROCHLORIDE is duloxetine hydrochloride. There are forty-two drug master file entries for this compound. Forty-eight suppliers are listed for this compound. Additional details are available on the duloxetine hydrochloride profile page.
Summary for 203088
Tradename: | DULOXETINE HYDROCHLORIDE |
Applicant: | Breckenridge |
Ingredient: | duloxetine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 203088
Mechanism of Action | Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 203088
Suppliers and Packaging for NDA: 203088
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DULOXETINE HYDROCHLORIDE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 203088 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-025 | 43353-025-30 | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (43353-025-30) |
DULOXETINE HYDROCHLORIDE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 203088 | ANDA | Aphena Pharma Solutions - Tennessee, LLC | 43353-025 | 43353-025-60 | 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (43353-025-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Jun 11, 2014 | 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: | Jun 11, 2014 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 60MG BASE | ||||
Approval Date: | Jun 11, 2014 | TE: | AB | RLD: | No |
Complete Access Available with Subscription