Details for New Drug Application (NDA): 078861
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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-eight suppliers are listed for this compound. Additional details are available on the sertraline hydrochloride profile page.
Summary for 078861
Tradename: | SERTRALINE HYDROCHLORIDE |
Applicant: | Aurobindo Pharma |
Ingredient: | sertraline hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 078861
Mechanism of Action | Cytochrome P450 2D6 Inhibitors Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 078861
Suppliers and Packaging for NDA: 078861
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SERTRALINE HYDROCHLORIDE | sertraline hydrochloride | CONCENTRATE;ORAL | 078861 | ANDA | NorthStar Rx LLC | 16714-601 | 16714-601-02 | 1 BOTTLE, PLASTIC in 1 CARTON (16714-601-02) / 60 mL in 1 BOTTLE, PLASTIC |
SERTRALINE HYDROCHLORIDE | sertraline hydrochloride | CONCENTRATE;ORAL | 078861 | ANDA | Rising Pharma Holdings, Inc. | 64980-409 | 64980-409-06 | 1 BOTTLE, PLASTIC in 1 CARTON (64980-409-06) / 60 mL in 1 BOTTLE, PLASTIC |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CONCENTRATE;ORAL | Strength | EQ 20MG BASE/ML | ||||
Approval Date: | Oct 31, 2008 | TE: | AA | RLD: | No |
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