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Generated: September 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202446

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NDA 202446 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: 202446

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

Pharmacology for NDA: 202446

Suppliers and Packaging for NDA: 202446

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMITRIPTYLINE HYDROCHLORIDE
amitriptyline hydrochloride
TABLET;ORAL 202446 ANDA Accord Healthcare Inc. 16729-171 16729-171-01 100 TABLET, FILM COATED in 1 BOTTLE (16729-171-01)
AMITRIPTYLINE HYDROCHLORIDE
amitriptyline hydrochloride
TABLET;ORAL 202446 ANDA Accord Healthcare Inc. 16729-171 16729-171-17 1000 TABLET, FILM COATED in 1 BOTTLE (16729-171-17)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jun 4, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Jun 4, 2014TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Jun 4, 2014TE:ABRLD:No


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