Details for New Drug Application (NDA): 085075
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NDA 085075 describes AEROLATE SR, which is a drug marketed by Fleming Pharms and is included in one NDA. Additional details are available on the AEROLATE SR profile page.
The generic ingredient in AEROLATE SR 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 AEROLATE SR 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 085075
| Tradename: | AEROLATE SR |
| Applicant: | Fleming Pharms |
| Ingredient: | theophylline |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 085075
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 260MG | ||||
| Approval Date: | Nov 24, 1986 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 130MG | ||||
| Approval Date: | Nov 24, 1986 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE, EXTENDED RELEASE;ORAL | Strength | 65MG | ||||
| Approval Date: | Nov 24, 1986 | TE: | RLD: | No | |||||
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