Details for New Drug Application (NDA): 204343
✉ 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-nine suppliers are listed for this compound. Additional details are available on the duloxetine hydrochloride profile page.
Summary for 204343
Tradename: | DULOXETINE HYDROCHLORIDE |
Applicant: | Hetero Labs Ltd Iii |
Ingredient: | duloxetine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 204343
Mechanism of Action | Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 204343
Suppliers and Packaging for NDA: 204343
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DULOXETINE HYDROCHLORIDE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 204343 | ANDA | Camber Pharmaceuticals, Inc. | 31722-168 | 31722-168-01 | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-168-01) |
DULOXETINE HYDROCHLORIDE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 204343 | ANDA | Camber Pharmaceuticals, Inc. | 31722-168 | 31722-168-05 | 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-168-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Aug 3, 2016 | 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: | Aug 3, 2016 | 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: | Aug 3, 2016 | TE: | AB | RLD: | No |
Complete Access Available with Subscription