THEOPHYLLINE | N019083 | B BRAUN MEDICAL INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Searle Research and Development FDA-1986-P-0253 G.D. Searle & Co. filed this citizen petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting permission to file an Abbreviated New Drug Application for a 400-mg strength of Theo-24 anhydrous theophylline controlled-release capsules, which would differ from the list | Other | 2019-07-16 | Granted | Searle Research and Development |
Citizen Petition from Searle Research and Development FDA-1986-P-0253 Searle Research and Development submitted this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 CFR 314.55(d) requesting permission to file an Abbreviated New Drug Application for a 400-mg strength of Theo-24 (anhydrous theophylline) controlled-release c | Other | 2019-07-16 | Granted | Searle Research and Development |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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