Details for New Drug Application (NDA): 011552
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NDA 011552 describes STELAZINE, which is a drug marketed by Glaxosmithkline and is included in one NDA. Additional details are available on the STELAZINE profile page.
The generic ingredient in STELAZINE is trifluoperazine hydrochloride. There are ten drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the trifluoperazine hydrochloride profile page.
The generic ingredient in STELAZINE is trifluoperazine hydrochloride. There are ten drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the trifluoperazine hydrochloride profile page.
Summary for 011552
| Tradename: | STELAZINE |
| Applicant: | Glaxosmithkline |
| Ingredient: | trifluoperazine hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 011552
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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