DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 085966
NDA 085966 describes AMITRIPTYLINE HYDROCHLORIDE, which is a drug marketed by Watson Labs, Accord Hlthcare, Am Therap, Ani Pharms Inc, Copley Pharm, Halsey, Lederle, Mutual Pharm, Mylan, Par Pharm, Pliva, Purepac Pharm, Roxane, Sandoz, Sun Pharm Inds Inc, Superpharm, Teva, Ucb Inc, Usl Pharma, Vangard, Vintage Pharms, West Ward, and Zydus Pharms Usa Inc, and is included in one hundred and eighteen NDAs. It is available from forty-five 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-five 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-five suppliers are listed for this compound. Additional details are available on the amitriptyline hydrochloride profile page.
Summary for 085966
| Tradename: | AMITRIPTYLINE HYDROCHLORIDE |
| Applicant: | Sandoz |
| Ingredient: | amitriptyline hydrochloride |
| Patents: | 0 |
| Therapeutic Class: | Antidepressants |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 085966
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | amitriptyline hydrochloride | TABLET;ORAL | 085966 | ANDA | NCS HealthCare of KY, Inc dba Vangard Labs | 0615-0829 | N | 0615-0829-39 |
| AMITRIPTYLINE HYDROCHLORIDE | amitriptyline hydrochloride | TABLET;ORAL | 085966 | ANDA | Sandoz Inc | 0781-1487 | N | 0781-1487-01 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | No | ||||
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