Details for New Drug Application (NDA): 207188
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NDA 207188 describes PAROXETINE MESYLATE, which is a drug marketed by Actavis Labs Fl Inc and Prinston Inc and is included in two NDAs. It is available from one supplier. Additional details are available on the PAROXETINE MESYLATE profile page.
The generic ingredient in PAROXETINE MESYLATE 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.
The generic ingredient in PAROXETINE MESYLATE 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 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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