Details for New Drug Application (NDA): 077206
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The generic ingredient in SERTRALINE HYDROCHLORIDE is sertraline hydrochloride. There are twenty-two drug master file entries for this compound. Forty-seven suppliers are listed for this compound. Additional details are available on the sertraline hydrochloride profile page.
Summary for 077206
Tradename: | SERTRALINE HYDROCHLORIDE |
Applicant: | Aurobindo Pharma |
Ingredient: | sertraline hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 077206
Mechanism of Action | Cytochrome P450 2D6 Inhibitors Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 077206
Suppliers and Packaging for NDA: 077206
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SERTRALINE HYDROCHLORIDE | sertraline hydrochloride | TABLET;ORAL | 077206 | ANDA | NorthStar Rx LLC | 16714-611 | 16714-611-01 | 30 TABLET, FILM COATED in 1 BOTTLE (16714-611-01) |
SERTRALINE HYDROCHLORIDE | sertraline hydrochloride | TABLET;ORAL | 077206 | ANDA | NorthStar Rx LLC | 16714-611 | 16714-611-02 | 60 TABLET, FILM COATED in 1 BOTTLE (16714-611-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
Approval Date: | Feb 6, 2007 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 50MG BASE | ||||
Approval Date: | Feb 6, 2007 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 100MG BASE | ||||
Approval Date: | Feb 6, 2007 | TE: | AB | RLD: | No |
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