Details for New Drug Application (NDA): 206937
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NDA 206937 describes FLUOXETINE HYDROCHLORIDE, which is a drug marketed by Barr, Dr Reddys Labs Ltd, Accord Hlthcare, Alembic Pharms Ltd, Ani Pharms, Apnar Pharma Lp, Aurobindo Pharma, Beximco Pharms Usa, Cadila Pharms Ltd, Carlsbad, Cr Double Crane, Granules, Heritage Pharms, Ivax Sub Teva Pharms, Landela Pharm, Marksans Pharma, Micro Labs, Mylan, Mylan Pharms Inc, Natco Pharma Usa, Sandoz, Sciegen Pharms Inc, Specgx Llc, Strides Pharma, Sun Pharm Inds Ltd, Teva, Teva Pharms Usa, Actavis Mid Atlantic, Aptapharma Inc, Bajaj, Chartwell Molecular, Lannett Co Inc, Nostrum Labs Inc, Novitium Pharma, Pharm Assoc, Pharmobedient Cnsltg, Saptalis Pharms, Alembic, Aurobindo Pharma Ltd, Dr Reddys, Fosun Pharma, G And W Labs Inc, Inventia Hlthcare, Lupin Ltd, Par Form, Par Pharm Inc, Rising, Slate Run Pharma, Taro, Torrent, Twi Pharms, and Upsher Smith Labs, and is included in sixty-six NDAs. It is available from sixty-eight suppliers. Additional details are available on the FLUOXETINE HYDROCHLORIDE profile page.
The generic ingredient in FLUOXETINE HYDROCHLORIDE is fluoxetine hydrochloride. There are twenty-seven drug master file entries for this compound. Sixty-nine suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.
The generic ingredient in FLUOXETINE HYDROCHLORIDE is fluoxetine hydrochloride. There are twenty-seven drug master file entries for this compound. Sixty-nine suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.
Summary for 206937
| Tradename: | FLUOXETINE HYDROCHLORIDE |
| Applicant: | Torrent |
| Ingredient: | fluoxetine hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 206937
| Mechanism of Action | Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 206937
Suppliers and Packaging for NDA: 206937
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | TABLET;ORAL | 206937 | ANDA | Torrent Pharmaceuticals Limited | 13668-443 | 13668-443-01 | 100 TABLET in 1 BOTTLE (13668-443-01) |
| FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | TABLET;ORAL | 206937 | ANDA | Torrent Pharmaceuticals Limited | 13668-443 | 13668-443-10 | 1000 TABLET in 1 BOTTLE (13668-443-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Oct 21, 2016 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Oct 21, 2016 | TE: | RLD: | No | |||||
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