Details for New Drug Application (NDA): 085789
✉ Email this page to a colleague
NDA 085789 describes TRIFLUOPERAZINE HYDROCHLORIDE, which is a drug marketed by Chartwell Rx, Wockhardt, Duramed Pharms Barr, Ivax Pharms, Mylan, Pom Pharma, Sandoz, and Watson Labs, and is included in twenty NDAs. It is available from six suppliers. Additional details are available on the TRIFLUOPERAZINE HYDROCHLORIDE profile page.
The generic ingredient in TRIFLUOPERAZINE HYDROCHLORIDE is trifluoperazine hydrochloride. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the trifluoperazine hydrochloride profile page.
The generic ingredient in TRIFLUOPERAZINE HYDROCHLORIDE is trifluoperazine hydrochloride. There is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the trifluoperazine hydrochloride profile page.
Summary for 085789
| Tradename: | TRIFLUOPERAZINE HYDROCHLORIDE |
| Applicant: | Sandoz |
| Ingredient: | trifluoperazine hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 085789
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRIFLUOPERAZINE HYDROCHLORIDE | trifluoperazine hydrochloride | TABLET;ORAL | 085789 | ANDA | Sandoz Inc. | 0781-8034 | 0781-8034-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0781-8034-01) |
| TRIFLUOPERAZINE HYDROCHLORIDE | trifluoperazine hydrochloride | TABLET;ORAL | 085789 | ANDA | REMEDYREPACK INC. | 70518-4686 | 70518-4686-0 | 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-4686-0) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
