Details for New Drug Application (NDA): 010571
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NDA 010571 describes COMPAZINE, which is a drug marketed by Glaxosmithkline and is included in seven NDAs. Additional details are available on the COMPAZINE profile page.
The generic ingredient in COMPAZINE is prochlorperazine. There are twenty-one drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the prochlorperazine profile page.
The generic ingredient in COMPAZINE is prochlorperazine. There are twenty-one drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the prochlorperazine profile page.
Summary for 010571
| Tradename: | COMPAZINE |
| Applicant: | Glaxosmithkline |
| Ingredient: | prochlorperazine maleate |
| Patents: | 0 |
Profile for product number 001
| 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| Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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 | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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| Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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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