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Details for New Drug Application (NDA): 086009
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NDA 086009 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, and is included in one hundred and eighteen NDAs. It is available from thirty-four 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. Thirty-four 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. Thirty-four suppliers are listed for this compound. Additional details are available on the amitriptyline hydrochloride profile page.
Summary for 086009
| Tradename: | AMITRIPTYLINE HYDROCHLORIDE |
| Applicant: | Mylan |
| Ingredient: | amitriptyline hydrochloride |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 086009
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | amitriptyline hydrochloride | TABLET;ORAL | 086009 | ANDA | Mylan Pharmaceuticals Inc. | 0378-2610 | 0378-2610-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2610-01) |
| AMITRIPTYLINE HYDROCHLORIDE | amitriptyline hydrochloride | TABLET;ORAL | 086009 | ANDA | Mylan Pharmaceuticals Inc. | 0378-2610 | 0378-2610-10 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-2610-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| 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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