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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 202446


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NDA 202446 describes AMITRIPTYLINE HYDROCHLORIDE, which is a drug marketed by Watson Labs, Accord Hlthcare, Aiping Pharm Inc, Am Therap, Ani Pharms, Aurobindo Pharma Usa, Breckenridge, Copley Pharm, Endo Operations, Halsey, Lederle, Mankind Pharma, Mutual Pharm, Par Pharm, Pliva, Purepac Pharm, Rising, Roxane, Rubicon, Sandoz, Sun Pharm Inds Inc, Superpharm, Teva, Ucb Inc, Unichem, Usl Pharma, Vangard, West Ward, and Zydus Pharms, and is included in one hundred and nineteen 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 202446
Pharmacology for NDA: 202446
Medical Subject Heading (MeSH) Categories for 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 Major Pharmaceuticals 0904-7184 0904-7184-61 100 BLISTER PACK in 1 CARTON (0904-7184-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
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)

Profile for product number 001

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

Profile for product number 002

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

Profile for product number 003

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

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