Details for New Drug Application (NDA): 085665
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NDA 085665 describes SUSTAIRE, which is a drug marketed by Roerig and is included in one NDA. Additional details are available on the SUSTAIRE profile page.
The generic ingredient in SUSTAIRE 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 SUSTAIRE 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 085665
| Tradename: | SUSTAIRE |
| Applicant: | Roerig |
| Ingredient: | theophylline |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 085665
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 100MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | 300MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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