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Details for New Drug Application (NDA): 085969

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NDA 085969 describes AMITRIPTYLINE HYDROCHLORIDE, which is a drug marketed by Par Pharm, Roxane, Purepac Pharm, Mylan, Teva, Watson Labs, Sun Pharm Inds Inc, Vangard, Vintage Pharms, Copley Pharm, Halsey, Mutual Pharm, Ani Pharms Inc, Ucb Inc, Lederle, Accord Hlthcare, West Ward, Superpharm, Sandoz, Am Therap, Usl Pharma, and Pliva, and is included in one hundred and seventeen NDAs. It is available from forty-three suppliers. Additional details are available on the AMITRIPTYLINE HYDROCHLORIDE profile page.

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

Summary for NDA: 085969

Therapeutic Class:Antidepressants
Formulation / Manufacturing:see details

Pharmacology for NDA: 085969

Suppliers and Packaging for NDA: 085969

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
amitriptyline hydrochloride
TABLET;ORAL 085969 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-0828 0615-0828-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-0828-39)
amitriptyline hydrochloride
TABLET;ORAL 085969 ANDA Sandoz Inc 0781-1486 0781-1486-01 100 TABLET, FILM COATED in 1 BOTTLE (0781-1486-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:No

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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.