ALBUTEROL SULFATE; IPRATROPIUM BROMIDE | A077063 | WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from REGCON Solutions FDA-2015-P-4916 · 5 docket documents REGCON Solutions filed this citizen petition under Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA amend the Orange Book to designate Watson's Ipratropium Bromide and Albuterol Sulfate Inhalation Solution ANDA 077063 as a second reference-listed drug for the same s | 505(q) | 2015-12-23 | Denied | REGCON Solutions |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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