Details for New Drug Application (NDA): 204815
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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 204815
Tradename: | DULOXETINE HYDROCHLORIDE |
Applicant: | Macleods Pharms Ltd |
Ingredient: | duloxetine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 204815
Mechanism of Action | Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 204815
Suppliers and Packaging for NDA: 204815
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DULOXETINE HYDROCHLORIDE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 204815 | ANDA | Macleods Pharmaceuticals Limited | 33342-160 | 33342-160-09 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-160-09) |
DULOXETINE HYDROCHLORIDE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 204815 | ANDA | Macleods Pharmaceuticals Limited | 33342-160 | 33342-160-10 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (33342-160-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Mar 23, 2017 | 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: | Mar 23, 2017 | 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: | Mar 23, 2017 | TE: | AB | RLD: | No |
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