Details for New Drug Application (NDA): 021299
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The generic ingredient in PEXEVA is paroxetine mesylate. There are thirty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the paroxetine mesylate profile page.
Summary for 021299
Tradename: | PEXEVA |
Applicant: | Sebela Ireland Ltd |
Ingredient: | paroxetine mesylate |
Patents: | 1 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 021299
Mechanism of Action | Serotonin Uptake Inhibitors |
Suppliers and Packaging for NDA: 021299
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PEXEVA | paroxetine mesylate | TABLET;ORAL | 021299 | NDA | Sebela Pharmaceuticals Inc. | 54766-201 | 54766-201-01 | 30 TABLET, FILM COATED in 1 BOTTLE (54766-201-01) |
PEXEVA | paroxetine mesylate | TABLET;ORAL | 021299 | NDA | Sebela Pharmaceuticals Inc. | 54766-202 | 54766-202-01 | 30 TABLET, FILM COATED in 1 BOTTLE (54766-202-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Jul 3, 2003 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Try a Trial | Patent Expiration: | May 4, 2025 | Product Flag? | Substance Flag? | Y | Delist Request? |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
Approval Date: | Jul 3, 2003 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Try a Trial | Patent Expiration: | May 4, 2025 | Product Flag? | Substance Flag? | Y | Delist Request? |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 30MG BASE | ||||
Approval Date: | Jul 3, 2003 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Try a Trial | Patent Expiration: | May 4, 2025 | Product Flag? | Substance Flag? | Y | Delist Request? |
Expired US Patents for NDA 021299
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