Details for New Drug Application (NDA): 085627
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NDA 085627 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.
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 085627
| Tradename: | AMITRIPTYLINE HYDROCHLORIDE |
| Applicant: | Mutual Pharm |
| Ingredient: | amitriptyline hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 085627
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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