Details for New Drug Application (NDA): 209293
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The generic ingredient in PAROXETINE HYDROCHLORIDE is paroxetine hydrochloride. There are thirty drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the paroxetine hydrochloride profile page.
Summary for 209293
Tradename: | PAROXETINE HYDROCHLORIDE |
Applicant: | Sciecure Pharma Inc |
Ingredient: | paroxetine hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 209293
Mechanism of Action | Serotonin Uptake Inhibitors |
Suppliers and Packaging for NDA: 209293
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209293 | ANDA | Rhodes Pharmaceuticals L.P. | 42858-703 | 42858-703-03 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42858-703-03) |
PAROXETINE HYDROCHLORIDE | paroxetine hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 209293 | ANDA | Rhodes Pharmaceuticals L.P. | 42858-703 | 42858-703-50 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42858-703-50) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 12.5MG BASE | ||||
Approval Date: | Jun 12, 2018 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 25MG BASE | ||||
Approval Date: | Jun 12, 2018 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 37.5MG BASE | ||||
Approval Date: | Jun 12, 2018 | TE: | AB | RLD: | No |
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