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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 214548


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NDA 214548 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-two 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-two suppliers are listed for this compound. Additional details are available on the amitriptyline hydrochloride profile page.
Summary for 214548
Tradename:AMITRIPTYLINE HYDROCHLORIDE
Applicant:Unichem
Ingredient:amitriptyline hydrochloride
Patents:0
Pharmacology for NDA: 214548
Medical Subject Heading (MeSH) Categories for 214548
Suppliers and Packaging for NDA: 214548
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 214548 ANDA Unichem Pharmaceuticals (USA), Inc. 29300-419 29300-419-01 100 TABLET, FILM COATED in 1 BOTTLE (29300-419-01)
AMITRIPTYLINE HYDROCHLORIDE amitriptyline hydrochloride TABLET;ORAL 214548 ANDA Unichem Pharmaceuticals (USA), Inc. 29300-419 29300-419-05 500 TABLET, FILM COATED in 1 BOTTLE (29300-419-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:May 19, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:May 19, 2021TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:May 19, 2021TE:ABRLD:No

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