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Last Updated: July 13, 2024

Details for New Drug Application (NDA): 217411


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NDA 217411 describes AMITRIPTYLINE HYDROCHLORIDE, which is a drug marketed by Watson Labs, Accord Hlthcare, Aiping Pharm Inc, Am Therap, Ani Pharms, Aurobindo Pharma Usa, Chemistry Hlth, Copley Pharm, 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, Vintage Pharms, 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 217411
Tradename:AMITRIPTYLINE HYDROCHLORIDE
Applicant:Rising
Ingredient:amitriptyline hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 217411
Medical Subject Heading (MeSH) Categories for 217411
Suppliers and Packaging for NDA: 217411
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 217411 ANDA Major Pharmaceuticals 0904-7410 0904-7410-61 100 BLISTER PACK in 1 CARTON (0904-7410-61) / 1 TABLET in 1 BLISTER PACK
AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 217411 ANDA Major Pharmaceuticals 0904-7411 0904-7411-61 100 BLISTER PACK in 1 CARTON (0904-7411-61) / 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 19, 2023TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:May 19, 2023TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:May 19, 2023TE:ABRLD:No

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