Details for New Drug Application (NDA): 090723
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The generic ingredient in DULOXETINE HYDROCHLORIDE 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 090723
Tradename: | DULOXETINE HYDROCHLORIDE |
Applicant: | Marksans Pharma |
Ingredient: | duloxetine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 090723
Mechanism of Action | Norepinephrine Uptake Inhibitors Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 090723
Suppliers and Packaging for NDA: 090723
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DULOXETINE HYDROCHLORIDE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 090723 | ANDA | MARKSANS PHARMA LIMITED | 25000-608 | 25000-608-06 | 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (25000-608-06) |
DULOXETINE HYDROCHLORIDE | duloxetine hydrochloride | CAPSULE, DELAYED REL PELLETS;ORAL | 090723 | ANDA | MARKSANS PHARMA LIMITED | 25000-609 | 25000-609-03 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (25000-609-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Dec 11, 2013 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 30MG BASE | ||||
Approval Date: | Dec 11, 2013 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, DELAYED REL PELLETS;ORAL | Strength | EQ 60MG BASE | ||||
Approval Date: | Dec 11, 2013 | TE: | RLD: | No |
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