Details for New Drug Application (NDA): 215376
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NDA 215376 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-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.
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 215376
| Tradename: | AMITRIPTYLINE HYDROCHLORIDE |
| Applicant: | Rubicon |
| Ingredient: | amitriptyline hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 215376
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AMITRIPTYLINE HYDROCHLORIDE | amitriptyline hydrochloride | TABLET;ORAL | 215376 | ANDA | Advagen Pharma Ltd | 72888-067 | 72888-067-00 | 1000 TABLET, FILM COATED in 1 BOTTLE (72888-067-00) |
| AMITRIPTYLINE HYDROCHLORIDE | amitriptyline hydrochloride | TABLET;ORAL | 215376 | ANDA | Advagen Pharma Ltd | 72888-067 | 72888-067-01 | 100 TABLET, FILM COATED in 1 BOTTLE (72888-067-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | May 1, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | May 1, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | May 1, 2023 | TE: | AB | RLD: | No | ||||
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