Details for New Drug Application (NDA): 207188
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The generic ingredient in PAROXETINE MESYLATE is paroxetine mesylate. There are thirty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the paroxetine mesylate profile page.
Summary for 207188
Tradename: | PAROXETINE MESYLATE |
Applicant: | Prinston Inc |
Ingredient: | paroxetine mesylate |
Patents: | 0 |
Pharmacology for NDA: 207188
Mechanism of Action | Serotonin Uptake Inhibitors |
Suppliers and Packaging for NDA: 207188
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PAROXETINE MESYLATE | paroxetine mesylate | CAPSULE;ORAL | 207188 | ANDA | Solco Healthcare LLC | 43547-409 | 43547-409-03 | 30 CAPSULE in 1 BOTTLE (43547-409-03) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | EQ 7.5MG BASE | ||||
Approval Date: | Aug 18, 2017 | TE: | AB | RLD: | No |
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