Details for New Drug Application (NDA): 085328
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NDA 085328 describes THEO-DUR, which is a drug marketed by Schering and is included in seven NDAs. Additional details are available on the THEO-DUR profile page.
The generic ingredient in THEO-DUR is theophylline. There are thirty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the theophylline profile page.
The generic ingredient in THEO-DUR is theophylline. There are thirty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the theophylline profile page.
Summary for 085328
| Tradename: | THEO-DUR |
| Applicant: | Schering |
| Ingredient: | theophylline |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 085328
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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TABLET, EXTENDED RELEASE;ORAL | Strength | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||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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