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Generated: November 20, 2017

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Details for New Drug Application (NDA): 071524

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NDA 071524 describes TRAZODONE HYDROCHLORIDE, which is a drug marketed by Mylan, Watson Labs, Alvogen, Mylan Pharms Inc, Quantum Pharmics, Accord Hlthcare, Teva Pharms Usa, Pliva, Sun Pharm Inds, Am Therap, Zydus Pharms Usa Inc, Teva, Apotex, Torrent Pharms Ltd, Sandoz, Aurolife Pharma Llc, Usl Pharma, Vintage, and Apotex Inc, and is included in twenty-eight NDAs. It is available from forty-four suppliers. Additional details are available on the TRAZODONE HYDROCHLORIDE profile page.

The generic ingredient in TRAZODONE HYDROCHLORIDE is trazodone hydrochloride. There are thirteen drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the trazodone hydrochloride profile page.

Summary for 071524

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for NDA: 071524

Suppliers and Packaging for NDA: 071524

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRAZODONE HYDROCHLORIDE
trazodone hydrochloride
TABLET;ORAL 071524 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-2579 0615-2579-05 15 TABLET in 1 BLISTER PACK (0615-2579-05)
TRAZODONE HYDROCHLORIDE
trazodone hydrochloride
TABLET;ORAL 071524 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-2579 0615-2579-31 31 TABLET in 1 BLISTER PACK (0615-2579-31)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:Dec 11, 1987TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

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Deloitte

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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