ACETAZOLAMIDE SODIUM | A040784 | XGEN PHARMACEUTICALS DJB INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Emcure Pharmaceuticals USA Inc. FDA-2014-P-0979 Emcure Pharmaceuticals USA Inc. filed this citizen petition under 21 U.S.C. § 355(j)(2)(c) requesting that the FDA find that Duramed Pharmaceuticals/Barr (Teva) discontinued marketing of DIAMOX (Acetazolamide Injection 500mg base/vial), approved under NDA 009-388, for reasons unrelated to safety and | 505(q) | 2014-07-17 | Withdrawn | Emcure Pharmaceuticals USA Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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