ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE | A040109 | MIKART LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Larken Laboratories, Inc. (Sovereign Pharmaceuticals, LLC - Citizen Petition FDA-2011-P-0096 · 6 docket documents Sovereign Pharmaceuticals LLC on behalf of Larken Laboratories Inc filed an ANDA Suitability Petition under 21 CFR 314.93 requesting permission to submit an abbreviated new drug application for Acetaminophen, Caffeine, Dihydrocodeine Bitartrate Tablets at 325 mg / 30 mg / 16 mg, a lower strength tha | Other | 2011-02-25 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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