ALBUTEROL SULFATE | A072619 | TEVA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition From Teva Pharmaceutical Industries, LTD (Teva Respiratory, ... FDA-2014-P-0404 Teva Pharmaceutical Industries Ltd. filed this citizen petition under 21 C.F.R. § 10.30 and section 505 of the FD&C Act requesting that the FDA refrain from approving generic or follow-on albuterol rescue inhalers without clinical use studies demonstrating dose counter accuracy and reliability, requ | 505(q) | 2014-04-10 | Partially Denied | Teva Pharmaceutical Industries |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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