Details for New Drug Application (NDA): 216953
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NDA 216953 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, Natco Pharma Usa, Norvium Bioscience, 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, Alembic, Aurobindo Pharma Ltd, Dr Reddys, Endo Operations, Fosun Pharma, G And W Labs Inc, Inventia Hlthcare, Lupin Ltd, Rising, Slate Run Pharma, Taro, Torrent, Twi Pharms, and Upsher Smith Labs, and is included in sixty-six NDAs. It is available from sixty-nine 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. Seventy 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. Seventy suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride profile page.
Summary for 216953
| Tradename: | FLUOXETINE HYDROCHLORIDE |
| Applicant: | Aptapharma Inc |
| Ingredient: | fluoxetine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 216953
| Mechanism of Action | Serotonin Uptake Inhibitors |
Medical Subject Heading (MeSH) Categories for 216953
Suppliers and Packaging for NDA: 216953
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | SOLUTION;ORAL | 216953 | ANDA | Upsher-Smith Laboratories, LLC | 0832-6032 | 0832-6032-12 | 1 BOTTLE in 1 CARTON (0832-6032-12) / 120 mL in 1 BOTTLE |
| FLUOXETINE HYDROCHLORIDE | fluoxetine hydrochloride | SOLUTION;ORAL | 216953 | ANDA | REMEDYREPACK INC. | 70518-3904 | 70518-3904-0 | 10 CUP, UNIT-DOSE in 1 BOX (70518-3904-0) / 5 mL in 1 CUP, UNIT-DOSE (70518-3904-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 20MG BASE/5ML | ||||
| Approval Date: | Nov 15, 2022 | TE: | AA | RLD: | No | ||||
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