Details for New Drug Application (NDA): 013483
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NDA 013483 describes DRIXORAL, which is a drug marketed by Schering Plough and is included in two NDAs. Additional details are available on the DRIXORAL profile page.
The generic ingredient in DRIXORAL is acetaminophen; dexbrompheniramine maleate; pseudoephedrine sulfate. There are sixty-six drug master file entries for this compound. Additional details are available on the acetaminophen; dexbrompheniramine maleate; pseudoephedrine sulfate profile page.
The generic ingredient in DRIXORAL is acetaminophen; dexbrompheniramine maleate; pseudoephedrine sulfate. There are sixty-six drug master file entries for this compound. Additional details are available on the acetaminophen; dexbrompheniramine maleate; pseudoephedrine sulfate profile page.
Summary for 013483
| Tradename: | DRIXORAL |
| Applicant: | Schering Plough |
| Ingredient: | dexbrompheniramine maleate; pseudoephedrine sulfate |
| Patents: | 0 |
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 6MG;120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Sep 13, 1982 | TE: | RLD: | Yes | |||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 6MG;120MG | ||||
| Approval Date: | Sep 13, 1982 | TE: | RLD: | No | |||||
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