Details for New Drug Application (NDA): 088004
✉ Email this page to a colleague
NDA 088004 describes THIORIDAZINE HYDROCHLORIDE, which is a drug marketed by Actavis Mid Atlantic, Alpharma Us Pharms, Ani Pharms, Epic Pharma Llc, Pharm Assoc, Sandoz, Wockhardt, Chartwell Rx, Heritage Pharma Avet, Mutual Pharm, Mylan, Par Pharm, Roxane, Sun Pharm Industries, Superpharm, Watson Labs, Watson Labs Teva, and West Ward, and is included in seventy-nine NDAs. It is available from three suppliers. Additional details are available on the THIORIDAZINE HYDROCHLORIDE profile page.
The generic ingredient in THIORIDAZINE HYDROCHLORIDE is thioridazine hydrochloride. There are eighteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the thioridazine hydrochloride profile page.
The generic ingredient in THIORIDAZINE HYDROCHLORIDE is thioridazine hydrochloride. There are eighteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the thioridazine hydrochloride profile page.
Summary for 088004
| Tradename: | THIORIDAZINE HYDROCHLORIDE |
| Applicant: | Mylan |
| Ingredient: | thioridazine hydrochloride |
| Patents: | 0 |
Suppliers and Packaging for NDA: 088004
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| THIORIDAZINE HYDROCHLORIDE | thioridazine hydrochloride | TABLET;ORAL | 088004 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0612 | 0378-0612-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0612-01) |
| THIORIDAZINE HYDROCHLORIDE | thioridazine hydrochloride | TABLET;ORAL | 088004 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0614 | 0378-0614-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0614-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | Nov 18, 1983 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Mar 15, 1983 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Mar 15, 1983 | TE: | RLD: | No | |||||
Complete Access Available with Subscription
