Details for New Drug Application (NDA): 208698
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NDA 208698 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, Cadila Pharms Ltd, Carlsbad, Chartwell Rx, Cr Double Crane, Heritage, Ivax Sub Teva Pharms, Landela Pharm, Marksans Pharma, Micro Labs, Natco Pharma Usa, Pharmobedient, Regcon Holdings, Sandoz, Sciegen Pharms, Specgx Llc, Strides Pharma Intl, Sun Pharm Inds Ltd, Teva, Teva Pharms Usa, Actavis Mid Atlantic, Bajaj, Chartwell Molecular, Lannett Co Inc, Novitium Pharma, Pharm Assoc, Pharmobedient Cnsltg, Solis Pharms, Upsher Smith Labs, Alembic, Aurobindo Pharma Ltd, Dr Reddys, Fosun Pharma, G And W Labs Inc, Inventia Hlthcare, Lupin Ltd, Ph Health, Rising, Somerset Theraps Llc, Strides Pharma, Torrent, and Twi Pharms, and is included in sixty-seven NDAs. It is available from sixty-three 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-four 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-four suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.
Summary for 208698
| Tradename: | FLUOXETINE HYDROCHLORIDE |
| Applicant: | Alembic |
| Ingredient: | fluoxetine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 208698
| Mechanism of Action | Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 208698
Suppliers and Packaging for NDA: 208698
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | TABLET;ORAL | 208698 | ANDA | Alembic Pharmaceuticals Limited | 46708-242 | 46708-242-30 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-242-30) |
| FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | TABLET;ORAL | 208698 | ANDA | Alembic Pharmaceuticals Limited | 46708-242 | 46708-242-31 | 100 TABLET, FILM COATED in 1 BOTTLE (46708-242-31) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
| Approval Date: | Apr 5, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 20MG BASE | ||||
| Approval Date: | Apr 5, 2017 | TE: | AB | RLD: | No | ||||
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