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Details for New Drug Application (NDA): 085966

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NDA 085966 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-four 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-four suppliers are listed for this compound. Additional details are available on the amitriptyline hydrochloride profile page.

Summary for NDA: 085966

amitriptyline hydrochloride
Therapeutic Class:Antidepressants

Pharmacology for NDA: 085966

Suppliers and Packaging for NDA: 085966

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
amitriptyline hydrochloride
TABLET;ORAL 085966 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-0829 0615-0829-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-0829-39)
amitriptyline hydrochloride
TABLET;ORAL 085966 ANDA Sandoz Inc 0781-1487 0781-1487-01 100 TABLET, FILM COATED in 1 BOTTLE (0781-1487-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

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