Details for New Drug Application (NDA): 078861
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NDA 078861 describes SERTRALINE HYDROCHLORIDE, which is a drug marketed by Almatica, Aurobindo Pharma, Ranbaxy Labs Ltd, Strides Pharma, Accord Hlthcare, Anda Repository, Appco, Ascent Pharms Inc, Chartwell Molecular, Granules, Heritage Pharma Avet, Hikma Pharms, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Mylan Pharms Inc, Norvium Bioscience, Oxford Pharms, Reyoung, Sciegen Pharms Inc, Sun Pharm Inds (in), Sun Pharm Inds Ltd, Torrent Pharms, Viwit Pharm, and Zydus, and is included in thirty-one NDAs. It is available from forty-six suppliers. Additional details are available on the SERTRALINE HYDROCHLORIDE profile page.
The generic ingredient in SERTRALINE HYDROCHLORIDE is sertraline hydrochloride. There are twenty-two drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the sertraline hydrochloride profile page.
The generic ingredient in SERTRALINE HYDROCHLORIDE is sertraline hydrochloride. There are twenty-two drug master file entries for this compound. Forty-nine 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 |
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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